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FDA MedWatch Alerts

FDA Label Changes are now available online and in our monthly newsletter update.

Sensorcaine-MPF (bupivacaine HCl) by Fresenius Kabi: Recall - Presence of Particulate Matter

April 26, 2016

Audience: Surgery, Dentistry, OBGYN, Nursing, Pharmacy. ISSUE: Fresenius Kabi USA announced today it is voluntarily recalling a single lot (Lot Number 6111504; Product Code 470237) of Sensorcaine®-MPF (bupivacaine HCl) Injection, USP, 0.75%, 7.5 mg/mL, 30 mL fill in a 30 mL vial. The recall is being performed to the user level due to visible particulate matter characterized as glass observed by the company during ...

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Fluconazole (Diflucan): Drug Safety Communication - FDA Evaluating Study Examining Use of Oral Fluconazole (Diflucan) in Pregnancy

April 26, 2016

Audience: Internal Medicine, Family Medicine, OB/GYN. ISSUE: FDA is evaluating the results of a Danish study that concludes there is a possible increased risk of miscarriage with the use of oral fluconazole (Diflucan) for yeast infections. FDA is also reviewing additional data and will communicate final conclusions and recommendations when the review is complete. The current FDA drug label states that data...

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Sterile Drug Products from Pharmakon Pharmaceuticals, Inc: CDER Statement - FDA alerts health care professionals not to use due to a lack of sterility assurance and other quality issues

April 16, 2016

Audience: Pharmacy, Nursing, Health Professional ISSUE: FDA is alerting health care professionals not to use any drug products that are intended to be sterile and are produced and distributed nationwide by Pharmakon Pharmaceuticals Inc., in Noblesville, Indiana, due to a lack of sterility assurance and other quality issues. BACKGROUND: FDA recently inspected Pharmakon’s facility following the company’s voluntary re...

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50 Percent Magnesium Sulfate Injection, USP by Hospira: Recall - Presence Of Particulate Matter

April 14, 2016

Audience: Pharmacy, Nursing, OB/GYN. [Posted 04/14/2016] ISSUE: Hospira, Inc. is voluntarily recalling one lot of 50% Magnesium Sulfate Injection, USP, 10 g/20 mL (0.5 g/ml), 20 mL Single-dose vials, Lot 50-343-DK, Expiration 01FEB2017, NDC 0409-2168-02, to the hospital level due to a confirmed customer complaint for the presence of particulate matter, within one single-dose fliptop vial. A recall was previously...

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Super Herbs Capsules: Recall - Undeclared Drug Ingredients

April 12, 2016

Audience: Consumer. [Posted 04/12/2016] ISSUE: Super Herbs is voluntarily recalling all bottles of SUPER HERBS, light green and dark green capsules to the consumer level after FDA laboratory testing found SUPER HERBS to contain sibutramine, desmethylsibutramine, and/or phenolphthalein. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Desmethylsibutramine is an...

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Metformin-containing Drugs: Drug Safety Communication - Revised Warnings for Certain Patients With Reduced Kidney Function

April 8, 2016

Audience: Pharmacy, Nephrology, Internal Medicine, Patient. ISSUE: FDA is requiring labeling changes regarding the recommendations for metformin-containing medicines for diabetes to expand metformin’s use in certain patients with reduced kidney function. The current labeling strongly recommends against use of metformin in some patients whose kidneys do not work normally. FDA was asked to review numerous medical s...

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Diabetes Medications Containing Saxagliptin and Alogliptin: Drug Safety Communication - Risk of Heart Failure

April 5, 2016

Audience: Pharmacy, Internal Medicine, Patient, Endocrinology. ISSUE: An FDA safety review has found that type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure, particularly in patients who already have heart or kidney disease. As a result, FDA is adding new warnings to the drug labels about this safety issue. Medicines containing saxagliptin and alogliptin...

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Continuum Labs LGD-4033 by Invisiblu International: Recall - Investigational Drug Not Approved for Use

April 5, 2016

Audience: Consumer. ISSUE: Invisiblu International LLC is voluntarily recalling one lot of Continuum Labs LGD-Xtreme, 3 mg to the retail and consumer level. The product has been found to contain LGD-4033 Ligandrol, an investigational drug not approved for use. The risks of using this product are unknown. The affected LGD-Xtreme lot numbers are 21511166 with expiration dates of 11/2018. BACKGROUND: LGD-Xtreme is...

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Sterile Drug Products by Medaus Pharmacy: FDA Alert - Lack of Sterility Assurance

April 1, 2016

Audience: Pharmacy, Nursing, Health Professional. [Posted 04/01/2016] ISSUE: FDA is alerting health care professionals and patients not to use unexpired drug products that are intended to be sterile that were produced by Medaus Pharmacy in Birmingham, Alabama, due to lack of sterility assurance. Medaus’ products were distributed nationwide and internationally. BACKGROUND: During FDA’s recent inspection of Med...

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5 Percent Dextrose Injection USP in PAB Container by B. Braun Medical: Recall - Leakage and/or Particulate Matter

March 29, 2016

Audience: Pharmacy, Nursing. ISSUE: B. Braun Medical Inc. is recalling one lot of 5% Dextrose Injection USP 100/150mL container (Lot #J5J706, catalog #S5104-5264, NDC 0264-1510-32) to the consumer level. B. Braun recently identified an adverse quality trend in customer complaints reporting that some containers in lot J5J706 exhibited leakage and, in a few instances, visible particulate matter identified to be...

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Compounded Products by Reliable Drug Pharmacy: Recall - Potential for Mislabeling and Lack of Quality Assurance

March 28, 2016

Audience: Pharmacy. [Posted 03/28/2016] ISSUE: Reliable Drug Pharmacy is recalling all unexpired lots of compounded products due to concern of lack of quality assurance and potential mislabeling. All unexpired lots are subject to the recall. All recalled products were distributed to patients and veterinarians within California. A few products were shipped to Hawaii, New Mexico, and Michigan. The recall was issued...

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Best Bentonite Clay by Best Bentonite: FDA Alert - Risk of Lead Poisoning

March 23, 2016

Audience: Consumer. [Posted 03/23/2016] ISSUE: FDA is warning consumers not to use “Best Bentonite Clay,” a product of Best Bentonite, located in Guthrie, Oklahoma. FDA has determined that the product contains elevated lead levels and may pose a lead poisoning risk. FDA laboratories have found elevated levels of lead in “Best Bentonite Clay.” Exposure to lead can cause serious damage to the central nervous system,...

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NOW Health Group Dietary Supplements: Recall - Mislabeling

March 22, 2016

Audience: Consumers. Includes: NOW Elderberry 500mg 60 VegCaps - Product Code 4667, Lot #1966914 (57 units) NOW Andrographis Ext 400 mg 90 VegCaps - Product Code 4591, Lot #1966914 (8 units) NOW Gingko Biloba 60mg 120 VegCaps - Product Code 4687, Lot #1969778 (77 units) NOW Burdock Root 430mg 100 Caps - Product Code 4608, Lot #1969778 (8 units) NOW Goldenseal Root 500mg 100 Caps - Product Code 4692, Lot...

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Opioid Pain Medicines: Drug Safety Communication - New Safety Warnings Added to Prescription Opioid Medications

March 22, 2016

Audience: Family Practice, Psychiatry, Pain Management, Nursing, Endocrinology. ISSUE: FDA is warning about several safety issues with the entire class of opioid pain medicines. See the FDA Drug Safety Communication for a complete listing. These safety risks are potentially harmful interactions with numerous other medications, problems with the adrenal glands, and decreased sex hormone levels. We are requiring c...

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Sodium Bicarbonate Injection, USP by Hospira: Recall - Particulate Matter

March 21, 2016

Audience: Pharmacy, Nursing. ISSUE: Hospira, Inc. is recalling one lot of 8.4% Sodium Bicarbonate Injection, USP (NDC: 0409-6625-02, Lot 56-148-EV, Expiry 1AUG2017) at the hospital/retail level due to the presence of a particulate within a single–dose glass fliptop vial. The issue was identified through a confirmed complaint. The product is packaged 50 mEq (1mEq/mL), 4.2 grams (84 mg/mL), 50mL, Single-dose, p...

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Eye Drops: FDA Statement - Potential Risk of Loose Safety Seals

March 15, 2016

Audience: Consumer, Eye Care. [Posted 03/15/2016] ISSUE: FDA is warning the public about eye drop bottles that have loose plastic safety seals or tamper evident rings below the bottle cap that may fall onto the eye when the product is used. See Safety Statement for example photo. FDA has received reports of six adverse events associated with loose safety seals on eye drop bottles. FDA is in the process of...

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Amikacin Sulfate Injection USP, 1 gram/4mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter

March 10, 2016

Audience: Pharmacy, Infectious Disease. ISSUE: Teva Pharmaceuticals announced a voluntary recall of one lot of amikacin sulfate injection USP, 1 gram/4mL (250 mg/mL) vials due to the potential presence of particulate matter identified as glass in one vial. The recalled lot # is 4750915, Expiration Date 9/2017. The administration of a glass particulate, if present in an intravenous drug, may result in local...

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Human and Animal Sterile Drug Products by I.V. Specialty: FDA Alert - Lack of Sterility Assurance

March 9, 2016

Audience: Pharmacy, Nursing, Veterinary Medicine, Infectious Disease. [Posted 03/09/2016] ISSUE: The U.S. Food and Drug Administration (FDA) is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by I.V. Specialty Ltd., Austin, Texas, due to lack of sterility assurance. On March 7, 2016, FDA recommended that I.V. Specialty cease sterile...

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Fluconazole Injection, USP, (in 0.9 Percent Sodium Chloride) 200mg per 100mL: Recall - Elevated Impurity

March 5, 2016

Audience: Infectious Disease, Pharmacy, Nursing. ISSUE: Sagent has initiated a voluntary recall of one lot of Fluconazole Injection, USP, 200mg per 100mL to the user level due to the discovery of an out of specification impurity result detected during routine quality testing of stability samples at the 18-month interval.  This impurity has been identified as Metronidazole.  An elevated impurity has the potential to d...

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0.9 Percent Sodium Chloride Solution for Irrigation by Baxter: Recall - Presence of Particulate Matter

February 18, 2016

Audience: Pharmacy. [Posted 02/18/2016] ISSUE: Baxter International is voluntarily recalling one lot of 0.9% Sodium Chloride Irrigation, USP, 500 mL Plastic Pour Bottle solution - Lot G120162, expiration 11/30/2018 - to the hospital/user level. This product is being recalled due to a customer complaint prior to use for the presence of particulate matter, identified as an insect. Sodium Chloride Irrigation s...

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