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Mapap FDA Alerts

The FDA Alert(s) below may be specifically about Mapap or relate to a group or class of drugs which include Mapap (acetaminophen).

MedWatch Safety Alerts are distributed by the FDA and published by Drugs.com. Following is a list of possible medication recalls, market withdrawals, alerts and warnings. For the latest FDA MedWatch alerts, go here.

Recent FDA Alert(s) for acetaminophen

Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength

Oct 15, 2015

Audience: Pharmacy, Consumer

ISSUE: On October 9, 2015, Medline Industries, Inc. announced that it will initiate a voluntary nationwide recall of lot # 45810 of Acetaminophen tablets, 500mg, uncoated compressed tablets to the consumer level. The Acetaminophen 500mg, Tab 100/BT (OTC20101) has been found to be mislabeled displaying “Acetaminophen 325mg” (OTC10101) instead of “Acetaminophen 500mg”. The Acetaminophen tablets, 500mg is incorrectly labeled as 325 mg tablets. This error is not easily identifiable by the user or prescriber. If the product is taken at the maximum labeled dose, every four hours, five doses a day, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure. See the firm Press Release for further details.

BACKGROUND: Acetaminophen tablets is an over the counter (OTC) oral medication used to temporarily relieve minor aches and pains due to minor pain of arthritis, muscular aches, back aches, headaches, toothaches, the common cold, premenstrual and menstrual cramps, and reduces fever. This item is packaged as 100 tablets per bottle, Medline Item Number: OTC20101, NDC#: 53329-641-30. The recalled Acetaminophen 500mg, Tab 100/BT (OTC20101) includes lot # 45810 with expiration date May 2018. This lot was distributed nationwide from June 12, 2015 through September 18, 2015.

RECOMMENDATION: Medline Industries, Inc. notified its distributors, consumers and/or retailer customers by First Class Mail on September 25th, 2015 and is arranging for return and credit of all recalled products. Consumers, distributors, and/or retailers that have product which is being recalled should stop using and return to Medline Industries, Inc.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.

[10/09/2015 - Press Release - Medline Industries]

Prescription and Over-the-Counter (OTC) Pain Medicines: Drug Safety Communication - FDA Review of Possible Risks of Pain Medicine Use During Pregnancy

Jan 9, 2015

Audience: OBGYN, Consumer

[Posted 01/09/2015]

ISSUE:  FDA is aware of and understands the concerns arising from recent reports questioning the safety of prescription and over-the-counter (OTC) pain medicines when used during pregnancy. As a result, FDA evaluated research studies published in the medical literature and determined they are too limited to make any recommendations based on these studies at this time. Because of this uncertainty, the use of pain medicines during pregnancy should be carefully considered. FDA urges pregnant women to always discuss all medicines with their health care professionals before using them.

Severe and persistent pain that is not effectively treated during pregnancy can result in depression, anxiety, and high blood pressure in the mother. Medicines including nonsteroidal anti-inflammatory drugs (NSAIDs), opioids, and acetaminophen can help treat severe and persistent pain. However, it is important to carefully weigh the benefits and risks of using prescription and OTC pain medicines during pregnancy. 

BACKGROUND: The published studies FDA reviewed reported on the potential risks associated with the following three types of pain medicines used during pregnancy. See the FDA Drug Safety Communication Data Summary section for more information about these studies.

RECOMMENDATION: Healthcare professionals should talk with each patient about the benefits and risks of analgesic use during pregnancy, which may differ among patients and by treatment indication. Continue to follow the existing recommendations in current drug labels regarding the use of analgesics during pregnancy.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[01/09/2015 - Drug Safety Communication - FDA]

Acetaminophen Prescription Combination Drug Products with more than 325 mg: FDA Statement - Recommendation to Discontinue Prescribing and Dispensing

Jan 14, 2014

Audience: Consumer, Dentistry, Emergency Medicine, Internal Medicine, Pharmacy, Pain Management, Surgery

ISSUE: FDA is recommending health care professionals discontinue prescribing and dispensing prescription combination drug products that contain more than 325 milligrams (mg) of acetaminophen per tablet, capsule or other dosage unit. There are no available data to show that taking more than 325 mg of acetaminophen per dosage unit provides additional benefit that outweighs the added risks for liver injury. Further, limiting the amount of acetaminophen per dosage unit will reduce the risk of severe liver injury from inadvertent acetaminophen overdose, which can lead to liver failure, liver transplant, and death.
 
Cases of severe liver injury with acetaminophen have occurred in patients who:

• took more than the prescribed dose of an acetaminophen-containing product in a 24-hour period;
• took more than one acetaminophen-containing product at the same time; or
• drank alcohol while taking acetaminophen products.

BACKGROUND: In January 2011 FDA asked manufacturers of prescription combination drug products containing acetaminophen to limit the amount of acetaminophen to no more than 325 mg in each tablet or capsule by January 14, 2014. FDA requested this action to protect consumers from the risk of severe liver damage which can result from taking too much acetaminophen. This category of prescription drugs combines acetaminophen with another ingredient intended to treat pain (most often an opioid), and these products are commonly prescribed to consumers for pain, such as pain from acute injuries, post-operative pain, or pain following dental procedures.

Acetaminophen is also widely used as an over-the-counter (OTC) pain and fever medication, and is often combined with other ingredients, such as cough and cold ingredients. FDA will address OTC acetaminophen products in another regulatory action. Many consumers are often unaware that many products (both prescription and OTC) contain acetaminophen, making it easy to accidentally take too much.

More than half of manufacturers have voluntarily complied with the FDA request. However, some prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit remain available. In the near future FDA intends to institute proceedings to withdraw approval of prescription combination drug products containing more than 325 mg of acetaminophen per dosage unit that remain on the market.

RECOMMENDATION: FDA recommends that health care providers consider prescribing combination drug products that contain 325 mg or less of acetaminophen. FDA also recommends that when a pharmacist receives a prescription for a combination product with more than 325 mg of acetaminophen per dosage unit that they contact the prescriber to discuss a product with a lower dose of acetaminophen. A two tablet or two capsule dose may still be prescribed, if appropriate. In that case, the total dose of acetaminophen would be 650 mg (the amount in two 325 mg dosage units). When making individual dosing determinations, health care providers should always consider the amounts of both the acetaminophen and the opioid components in the prescription combination drug product.

Health care providers and pharmacists who have further questions are encouraged to contact the Division of Drug Information at 888.INFO.FDA (888-463-6332) or druginfo@fda.hhs.gov.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[01/14/2014 -  FDA Statement - FDA]
[Acetaminophen Information - FDA]

Perrigo Acetaminophen Infant Suspension Liquid: Recall - Potential Defect with Co-packaged Oral Syringe

Nov 2, 2013

Audience: Consumer, Patient, Pediatrics, Pharmacy, Health Professional

ISSUE: The Perrigo Company announced that it has initiated a voluntary, nationwide product recall to the retail level of 18 batches of its acetaminophen infant suspension liquid, 160 mg/5 mL, sold in 2 oz. and 4 oz. bottles with syringes in a box under store brand products including Babies R Us, Care One and more  (refer to the Firm Press Release for full list of affected brand names and products).

The recall is being initiated because of the remote potential that a small number of packages might contain an oral dosing syringe without dose markings. Using an oral syringe without dose markings can result in inaccurate dosing, especially in infants who could mistakenly get too high a dose.

BACKGROUND:  This over the counter product is indicated for the relief of fever and minor aches and pains and can be used in infants, children and adults. These recalled products are sold by distributors nationwide and distributed through retail stores.

RECOMMENDATION: If the oral dosing device contained in the package has dose markings (for 1.25 mL, 2.5 mL, 3.75 mL, and 5 mL), no action is required, and the consumer can continue to use the product consistent with the label instructions. If the package contains an oral dosing device that does not have dose markings, the consumer should not use the product and should call Perrigo’s Consumer Affairs Department, toll free, 1-800-719-9260. Consumers should contact their physician or healthcare provider if they have any questions, or if they or their children experience any problem that could possibly be related to this drug product.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[11/01/2013 - Firm Press Release - Perrigo]

Acetaminophen: Drug Safety Communication - Association with Risk of Serious Skin Reactions

Aug 1, 2013

Audience: Dermatology, Primary Care, Pharmacy

ISSUE: FDA notified healthcare professionals and patients that acetaminophen has been associated with a risk of rare but serious skin reactions. Acetaminophen is a common active ingredient to treat pain and reduce fever; it is included in many prescription and over-the-counter (OTC) products.  These skin reactions, known as Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP), can be fatal. These reactions can occur with first-time use of acetaminophen or at any time while it is being taken.  Other drugs used to treat fever and pain/body aches (e.g., non-steroidal anti-inflammatory drugs, or NSAIDS, such as ibuprofen and naproxen) also carry the risk of causing serious skin reactions, which is already described in the warnings section of their drug labels.

BACKGROUND: This new information resulted from the Agency’s review of the FDA Adverse Event Reporting System (FAERS) database and the medical literature to evaluate cases of serious skin reactions associated with acetaminophen (see Data Summary at link below).  It is difficult to determine how frequently serious skin reactions occur with acetaminophen, due to the widespread use of the drug, differences in usage among individuals (e.g., occasional vs. long-term use), and the long period of time that the drug has been on the market; however it is likely that these events (i.e., SJS, TEN, and AGEP) occur rarely.

RECOMMENDATIONS: Health care professionals should be aware of this rare risk and consider acetaminophen, along with other drugs already known to have such an association, when assessing patients with potentially drug-induced skin reactions. Any patient who develops a skin rash or reaction while using acetaminophen or any other pain reliever/fever reducer should stop the drug and seek medical attention right away.  Anyone who has experienced a serious skin reaction with acetaminophen should not take the drug again and should contact their health care professional to discuss alternative pain relievers/fever reducers.

FDA will require that a warning be added to the labels of prescription drug products containing acetaminophen to address the risk of serious skin reactions. FDA will also request that manufacturers add a warning about serious skin reactions to the product labels of OTC acetaminophen drug products marketed under a new drug application and will encourage manufacturers of drug products marketed under the OTC monograph do the same.

[8/01/2013 - Consumer Update - FDA]

[8/01/2013 - Drug Safety Communication - FDA]

Infants' Tylenol Oral Suspension, 1 oz. Grape: Recall - Dosing System Complaints

Feb 17, 2012

Audience: Consumer, Pharmacy

ISSUE: McNeil Consumer Healthcare notified the public of a recall of seven lots (approximately 574,000 bottles) of Infants’ TYLENOL Oral Suspension, 1 oz. Grape. There were complaints from consumers who reported difficulty using the Infants’ TYLENOL SimpleMeasure dosing system. SimpleMeasure includes a dosing syringe, which a parent or caregiver inserts into a protective cover, or “flow restrictor,” at the top of the bottle to measure the proper dose. In some cases, the flow restrictor was pushed into the bottle when inserting the syringe.

BACKGROUND: Infants’ TYLENOL is an over-the-counter (OTC) product indicated as a pain reliever/fever reducer. The product was distributed nationwide in the United States.

RECOMMENDATION: If the flow restrictor is pushed into the bottle, the parent or caregiver should not use the product. See the Press Release for lot number and UPC codes of affected product. Consumers can visit www.tylenol.com for additional information.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[02/17/2012 - Press Release - McNeil Consumer Healthcare]

[02/17/2012 - Product Photo - FDA]

Liquid Acetaminophen marketed for infants: Drug Safety Communication - Potential for Dosing Errors

Dec 22, 2011

Audience: Pediatrics, Consumers, Pharmacy

[Posted 12/22/2011]

ISSUE: The FDA is informing the public that an additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available.  This change in the concentration will affect the amount of liquid given to an infant, and should be especially noted if someone is accustomed to using the 80 mg /0.8 mL or 80 mg/mL concentrations of liquid acetaminophen.

BACKGROUND:  Over-the-Counter (OTC) Liquid acetaminophen is used to temporarily reduce fever and relieve minor aches and pains due to the common cold, flu, headache, minor sore throat, and toothache. Acetaminophen is marketed under brand names such as Tylenol, Little Fevers,  Triaminic, Infant/Pain Reliever, Pedia Care, Triaminic Infants’ Syrup Fever Reducer Pain Reliever and other store brands (e.g., Rite Aid, CVS, Walgreens brand, etc.).

This change in the concentration will affect the amount of liquid given to an infant, and should be especially noted if someone is accustomed to using the 80 mg /0.8 mL or 80 mg/mL concentrations of liquid acetaminophen. In addition to this change in concentration, this product may also be packaged with an oral syringe instead of a dropper.

RECOMMENDATION: Read the Drug Facts label on the package to identify the concentration of the liquid acetaminophen (in mg/mL), dosage, and directions for use.  

Use the dosing device provided with the product in order to correctly measure the amount of liquid acetaminophen to be given. Healthcare professionals should provide directions to patients that specify the concentration and dose of liquid acetaminophen that should be given to a child.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 

[12/22/2011 - Drug Safety Communication - FDA]
[12/22/2011 - Consumer Update - FDA]
[12/22/2011 - Podcast - FDA]

[12/22/2011 - Questions and Answers - FDA]

Tylenol Extra Strength Caplets, 225 count bottles: Recall - Uncharacteristic Odor

Jun 29, 2011

Audience: Pharmacy, Consumer

ISSUE: McNeil Consumer Healthcare is recalling one product lot of Tylenol Extra Strength Caplets, 225 count bottles, distributed in the U.S. The recall stems from a small number of odor reports, including musty, moldy odor. The uncharacteristic musty, moldy odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA). While not considered to be toxic, TBA can generate an offensive odor and has been associated with temporary and non-serious gastrointestinal symptoms.

BACKGROUND: The Tylenol lot ABA619 - which includes 60,912 bottles - was manufactured in February, 2009. The product lot number for the recalled product can be found on the side of the bottle label.

RECOMMENDATION: Consumers who purchased product from the lot included in this recall should stop using the product and contact McNeil Consumer Healthcare, either at www.tylenol.com or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

 
[06/28/2011 - Press Release - McNeil Consumer Healthcare]

Tylenol 8 Hour Caplets 50 Count: Recall

Oct 19, 2010

Audience: Consumer, Pharmacy

Lot number: BCM155

ISSUE: McNeil is recalling Tylenol 8 Hour caplets 50 count bottles to the retail level following a small number of complaints of a musty or moldy odor. The uncharacteristic odor is thought to be caused by the presence of trace amounts of a chemical called 2,4,6-tribromoanisole.

BACKGROUND: This voluntary action is being taken as a precaution and the risk of adverse medical events is remote. To date, observed events reported to McNeil were temporary and non-serious. The product lot number for the recalled product can be found on the side of the bottle label.

RECOMMENDATION: Consumers should stop using the affected product and contact McNeil Consumer Healthcare, either at www.tylenol.com or by calling 1-888-222-6036 (Monday-Friday 8 a.m. to 8 p.m. Eastern Time, and Saturday-Sunday 9 a.m. to 5 p.m. Eastern Time) for instructions about receiving a refund or product coupon. Consumers who have medical concerns or questions should contact their healthcare provider.

[10/19/2010 - Press Release - McNeil Consumer Healthcare]
 

    

Acetaminophen 500 mg Caplets by Perrigo Company

Nov 9, 2006

Audience: Healthcare professionals and consumers

[Posted 11/09/2006] FDA and Perrigo Company notified the public of a voluntary recall of 383 lots of acetaminophen 500 mg caplets manufactured and distributed under various store-brands as a result of small metal fragments found in a small number of these caplets. Consumers can determine if they are in possession of a recalled product by locating the batch number printed on the container label. A list of stores that carry store-brands potentially affected by this recall, as well as batch numbers affected, is located on FDA's website (referenced below).

To date, there have been no illness or injuries received related to this problem and no consumer complaints have been reported to the FDA or to Perrigo. Based on information currently available, the FDA believes the probability of serious adverse health consequences is remote; however, if a consumer were to swallow an affected caplet, it could result in minor stomach discomfort and/or possible cuts to the mouth or throat. Consumers should consult their physician if they suspect they've been harmed by use of this product.

[November 9, 2006 - News Release - FDA]

Goldline Brand Extra Strength Genapap and Extra Strength Genebs

May 2, 2006

Audience: Consumers and pharmacists

[Posted 05/03/2006] FDA and IVAX Pharmaceuticals, Inc. notified healthcare professionals of a recall of Goldline brand Extra Strength Genapap 500mg (Acetaminophen) Caplets and Tablets and Extra Strength Genebs 500mg (Acetaminophen) Caplets and Tablets due to a labeling error. Specifically, the product label should indicate that usage should not exceed 8 tablets or caplets in a 24 hour period. The erroneous label indicates not to exceed 12 tablets or caplets in a 24 hour period. In the event the maximum dosage of 8 tablets or caplets in a 24 hour period is exceeded, there may be an increased risk of acetaminophen toxicity to the liver, which may cause adverse health effects. There have been no reports of serious illness or injury relating to this labeling matter.

[May 02, 2006 - Recall Notice - IVAX Pharmaceuticals, Inc.]

Perrigo Infants’ Oral Drops Containing Enclosed Syringe

Aug 2, 2005

Audience: Pharmacists, Pediatricians and other healthcare professionals

[Posted 08/02/2005] Perrigo and FDA notified healthcare professionals and consumers of the recall of all lots of concentrated infants’ drops that are packaged with a dosing syringe bearing only a “1.6 mL” mark containing:

1. acetaminophen,
2. acetaminophen, dextromethorphan HBr, and pseudoephedrine HCl, or
3. dextromethorphan HBr, and pseudoephedrine HCl.

The dosing syringe may be confusing in determining the proper dose for infants under 2 years of age as directed by a doctor and could lead to improper dosing, including overdosing. The following products are being recalled:

* Cherry Flavor Infant Pain Reliever 160 mg Acetaminophen (0.5oz. and 1.0oz)
* Grape Flavor Infant Pain Reliever 160 mg Acetaminophen (0.5oz. and 1.0oz)
* Cherry Flavor Cough and Cold Infant Drops (0.5oz)
* Cherry Flavor Decongestant and Cough Infant Drops (0.5oz)

OTC pain and fever reducers (acetaminophen / NSAIDs)

Jan 22, 2004

Audience: Pharmacists, other healthcare professionals, and consumers

The FDA notified healthcare professionals of a national education campaign to provide advice on the safe use of over-the-counter (OTC) pain and fever reducers that contain acetaminophen and non-steroidal anti-inflammatory drugs (NSAIDs). The campaign is intended to raise consumer awareness of these safety issues and to inform healthcare providers about the role that they can play in preventing acetaminophen induced hepatotoxicity and NSAID-related gastrointestinal bleeding and renal toxicity in patients using these medicines.

[January 22, 2004 Drug Information Page - FDA]
[January 22, 2004 Science Backgrounder - FDA]
[January 22, 2004 Letter to State Boards of Pharmacy - FDA]
[January 22, 2004 Press Release - FDA]

Acetaminophen, Dixon's 325 mg Tablet, Regular Strength

Dec 8, 2003

Audience: Pharmacists and consumers

Magno-Humphries, Inc., in cooperation with the FDA, voluntarily recalled one lot (504 bottles) of Dixon's®, APAP Acetaminophen 325 mg Analgesic Tablets, an over-the-counter drug product sold in 100 Tablet bottles with lot number 319687, Expiration Date 03/05. The tablets contained in the mislabeled bottles are 500 mg Acetaminophen, instead of 325 mg Acetaminophen. Overdoses of acetaminophen can lead to severe health problems including liver toxicity and liver failure. The acetaminophen was sold under the Dixon's® label at retail stores and pharmacies nationwide beginning in August 2003.

[December 4, 2003 Recall Notice - FDA]

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