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FDA MedWatch Alerts

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Eyesaline Eyewash by Honeywell: Recall - Microbial Contamination

August 22, 2016

Audience: Risk Manager, Emergency Medicine, Pharmacy. ISSUE: Honeywell is voluntarily recalling one production lot of 32-ounce bottles of Eyesaline Eyewash solution, which is used for emergency eye rinsing after an injury. Although no injuries have been reported and no contamination was found in batch testing, there is a risk of product contamination with Klebsiella pneumoniae. Although found in the normal flora of...

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Oxacillin for Injection, USP, 10g by Sagent: Recall - Iron Oxide Particulate Matter

August 19, 2016

Audience: Pharmacy. ISSUE: Sagent Pharmaceuticals, Inc. announced the voluntary nationwide recall of one lot of Oxacillin for Injection, USP, 10 g (NDC 25021-163-99) Lot OXT512 (Exp. Date March 2017) manufactured by Astral SteriTech Private Limited and distributed by Sagent. Sagent initiated this recall to the user level due to the receipt of a product complaint for a single vial containing small, dark particulate...

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Cetylev (acetylcysteine) Effervescent Tablets for Oral Solution: Recall - Inadequate Seal of Blister Pack

August 18, 2016

Audience: Pharmacy, Nursing, Emergency Medicine. ISSUE: Arbor  Pharmaceuticals, LLC announced a voluntary recall of three (3) lots of Cetylev (acetylcysteine) effervescent tablets for oral solution, 500 mg, due to an inadequate seal of the blister pack. An inadequate seal could result in an increase of oxygen and moisture entering the blister cavity which can start the effervescent process. This results in enlarged ...

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DHZC-2 Tablet by Ton Shen Health: Recall - Possible Health Risk

August 12, 2016

Audience: Consumer. ISSUE: Ton Shen Health of Chicago, IL, is recalling its “DHZC-2” Tablets because they have the potential to be contaminated with elevated levels of lead, a naturally occurring element which can affect multiple body system and particularly harmful to young children. Lead poisoning can happen if a person is exposed to high levels of lead over short period of time. One illness has been reported to da...

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Liquid Drug and Dietary Supplement Products by PharmaTech: Recall - Risk of Product Contamination

August 9, 2016

Audience: Pediatrics, Pharmacy, Family Practice, Consumer. ISSUE: PharmaTech, LLC is voluntarily recalling all liquid products due to a potential risk of product contamination with Burkholderia cepacia. See the press release for a complete listing of affected products. Drug products include: Aller-chlor Antihistamine Diocto Syrup Docusate Sodium Ninjacof Ninjacof A Senexion Liquid Senna Syrup Sennazon...

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0.25 Percent Bupivacaine Hydrochloride Injection, USP by Hospira: Recall - Particulate Matter

August 5, 2016

Audience: Pharmacy, Risk Manager, OBGYN, Dentistry. ISSUE: Hospira, Inc., a Pfizer company, is voluntarily recalling one lot of 0.25% Bupivacaine Hydrochloride Injection, USP (NDC: 0409-1159-02, Lot 59-064- DK, Expiry 1NOV2017) at the hospital/retail level due to the presence of particulate matter within a single vial. In the event that the particulate is administered to a patient, it may result in local swelling,...

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Amikacin Sulfate Injection USP 500 mg/2 mL (250 mg/mL) and 1 Gram/4 mL (250 mg/mL) Vials by Teva: Recall - Glass Particulate Matter

August 3, 2016

Audience: Pharmacy, Nursing. ISSUE: Teva Pharmaceuticals announced a voluntary recall of seven lots of Amikacin Sulfate Injection USP, 500 mg/2mL (250 mg/mL) and 1 gram/4mL (250 mg/mL) vials due to the potential for the presence of glass particulate matter. The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material....

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Fluoroquinolone Antibacterial Drugs for Systemic Use: Drug Safety Communication - Warnings Updated Due to Disabling Side Effects

July 26, 2016

Audience: Family Practice, Infectious Disease, Neurology, Pharmacy, Patient. ISSUE: FDA approved changes to the labels of fluoroquinolone antibacterial drugs for systemic use (i.e., taken by mouth or by injection). Includes the following currently available fluoroquinolones: Avelox (moxifloxacin) Cipro (ciprofloxacin) Cipro extended-release (ciprofloxacin extended-release) Factive (gemifloxacin) Levaquin...

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HCG and Sermorelin by Talon Compounding Pharmacy: Recall - Lack of Sterility Assurance

July 22, 2016

Audience: Patient, Pharmacy. ISSUE: Talon Compounding Pharmacy (TCP) voluntarily recalled all lots of lyophilized HCG and sermorelin aseptically compounded and packaged by TCP and that remain within expiry due to FDA concern over a lack of sterility assurance. Administration of a sterile drug product intended to be sterile that is compromised can result in health hazards including risk of serious infection or other...

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Oral Liquid Docusate Sodium by PharmaTech : Recall - Contaminated with B. cepacia

July 16, 2016

Audience: Health Professional. ISSUE: The FDA is alerting health care professionals that PharmaTech LLC, Davie, Florida, is voluntarily recalling all non-expired lots of Diocto Liquid, a docusate sodium solution distributed by Rugby Laboratories, Livonia, Michigan. The agency confirmed the product has been contaminated with Burkholderia cepacia, a bacteria linked to an outbreak in five states. In addition, FDA has...

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Canagliflozin (Invokana, Invokamet) and Dapagliflozin (Farxiga, Xigduo XR): Drug Safety Communication - Strengthened Kidney Warnings

June 14, 2016

Audience: Endocrinology, Internal Medicine, Nephrology, Pharmacy. ISSUE: FDA has strengthened the existing warning about the risk of acute kidney injury for the type 2 diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR).  Based on recent reports, we have revised the warnings in the drug labels to include information about acute kidney injury and added recommendations to ...

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Nature Made (Various Products) by Pharmavite LLC: Recall - Possible Health Risk

June 8, 2016

Audience: Consumer. [Posted 06/08/2016] ISSUE: Pharmavite LLC is recalling specific lots of Nature Made products due to possible Salmonella or Staphylococcus aureus contamination. Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever,...

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Step 2 60 Gold by The Body Shot Bar: Recall - Undeclared Drug Ingredients

June 7, 2016

Audience: Consumer. [Posted 06/07/2016] ISSUE: The Body Shot Bar is voluntarily recalling all lots distributed March 1- May 6 2016 of Step 2 60 gold capsule (350MG per) capsules to the consumer level. Step 2 has been found positive for Sibutramine after FDA sampling and testing. Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially...

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Loperamide (Imodium): Drug Safety Communication - Serious Heart Problems With High Doses From Abuse and Misuse

June 7, 2016

Audience: Pharmacy, Cardiology, Internal Medicine, Pain Management, Consumer. ISSUE: FDA is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms,...

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Over-the-Counter Antacid Products Containing Aspirin: FDA Drug Safety Communication - Serious Bleeding Risk

June 6, 2016

Audience: Consumer. ISSUE: The FDA is warning consumers about the risk of serious bleeding when using nonprescription, also known as over-the-counter or OTC, aspirin-containing antacid products to treat heartburn, sour stomach, acid indigestion, or upset stomach. Many other products for these conditions are available that do not contain aspirin. These widely used products already contain warnings about this...

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Zecuity (sumatriptan) Migraine Patch: Drug Safety Communication - FDA Evaluating Risk of Burns and Scars

June 2, 2016

Audience: Internal Medicine, Pain Management, Neurology, Pharmacy. ISSUE: FDA is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. Since marketing of the Zecuity patch began in September 2015, a large number of patients have reported they experienced burns or scars on the skin where the patch...

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Nizoral (ketoconazole) Oral Tablets: Drug Safety Communication - Prescribing for Unapproved Uses including Skin and Nail Infections Continues; Linked to Patient Death

May 19, 2016

Audience: Dermatology, Family Practice, Pharmacy, Patient. ISSUE: FDA is warning health care professionals to avoid prescribing the antifungal medicine ketoconazole oral tablets to treat skin and nail fungal infections. Use of this medication carries the risk of serious liver damage, adrenal gland problems, and harmful interactions with other medicines that outweigh its benefit in treating these conditions, which...

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Well Care Compounding Pharmacy Sterile Compounded Products: Recall - Lack Of Sterility Assurance

May 18, 2016

Audience: Pharmacy, Veterinary Medicine. [Posted 05/18/2016] ISSUE: Well Care Compounding Pharmacy is performing a voluntary statewide recall in Nevada on all unexpired sterile compounded products due to FDA concern over lack of sterility assurance. The recall impacts all sterile compounded products distributed between 01/01/2016-04/29/2016. Well Care Compounding Pharmacy is conducting this recall after an FDA...

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Canagliflozin (Invokana, Invokamet): Drug Safety Communication - Clinical Trial Results Find Increased Risk of Leg and Foot Amputations

May 18, 2016

Audience: Internal Medicine, Family Practice, Pharmacy, Patient. ISSUE: FDA is alerting the public about interim safety results from an ongoing clinical trial that found an increase in leg and foot amputations, mostly affecting the toes, in patients treated with the diabetes medicine canagliflozin (Invokana, Invokamet). FDA has not determined whether canagliflozin increases the risk of leg and foot amputations. FDA...

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SOS Telecom Products: Recall - Undeclared Drug Ingredient

May 13, 2016

Audience: Consumer. [Posted 05/13/2016] ISSUE: SOS Telecom, Inc. is voluntarily recalling all lots of the following products to the consumer level because these products were tested by the FDA and found to contain Sildenafil, and analogs of Sildenafil.  Sildenafil is a PDE-5 Inhibitor which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED), making these products tainted dietary ...

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