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FDA MedWatch Alerts

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

Sterile Products by Wells Pharmacy Network: Recall - Concern for Lack of Sterility Assurance

September 22, 2016

Audience: Pharmacy, Patient. [Posted 09/22/2016] ISSUE: Wells Pharmacy Network is voluntarily recalling all sterile human and veterinary products prepared between February 22, 2016 and September 14, 2016, and that remain within expiry due to FDA concern over a lack of sterility assurance. See the press release for a listing of affected prodcuts and lot numbers. Administration of a drug product intended to be...

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Hyoscyamine sulfate 0.125mg by Virtus Pharmaceuticals: Recall - Superpotent and Subpotent Test Results

September 15, 2016

Audience: Pharmacy, Gastroenterology, Pulmonology, Patient. ISSUE: Virtus Pharmaceuticals Opco II, LLC (Virtus) is voluntarily recalling seven batches of Hyoscyamine sulfate (0.125mg) to the consumer level which include the tablet, sublingual, and orally disintegrating tablet form. This recall is being initiated due to both superpotent and subpotent test results. All of these batches were manufactured by Pharmatech...

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GlucaGen HypoKit (glucagon [rDNA origin] for injection) by Novo Nordisk Inc: Recall - Detached Needles on Syringe

September 9, 2016

Audience: Pharmacy, Patient. ISSUE: Novo Nordisk Inc. is recalling six batches of the GlucaGen HypoKit in the U.S. due to two customer complaints from the UK and Portugal involving detached needles on the syringe with Sterile Water for Injection (SWFI). A syringe with a detached needle cannot be used as prescribed. Untreated hypoglycemia can eventually lead to unconsciousness and seizures, which can prove fatal. If...

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Family Care Eye Wash by United Exchange Corp: Recall - Microbial Contamination

September 8, 2016

Audience: Consumers, Eye Care, Pharmacy. [Posted 09/08/2016] ISSUE:  United Exchange Corp. is voluntarily recalling specific lots of Family Care Eye Wash 4 oz due to microbial contamination. These products consist of a purified water solution. Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a potentially sight threatening eye infection. See the ...

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Eye Wash/Eye Irrigating Solutions Distributed by Major Pharmaceuticals and Rugby Laboratories: Recall - Microbial Contamination

September 7, 2016

Audience: Consumers, Eye Care, Pharmacy. ISSUE: United Exchange Corp. of Cerritos, CA, a primary source vendor of the Rugby-branded Eye Irrigating Solution and Major-branded Eye Wash, is voluntarily recalling products due to microbial contamination. These products consist of a purified water solution. Use of a contaminated product could be calamitous for any population since there is a reasonable probability of a...

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Ovarian Cancer Screening Tests: Safety Communication - FDA Recommends Against Use

September 7, 2016

Audience: Patient, OBGYN, Oncology. ISSUE: The FDA is alerting women about the risks associated with the use of tests being marketed as ovarian cancer screening tests. The Agency is especially concerned about delaying effective preventive treatments for women who show no symptoms, but who are still at increased risk for developing ovarian cancer. Despite extensive research and published studies, there are currently...

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Opioid Pain or Cough Medicines Combined With Benzodiazepines: Drug Safety Communication - FDA Requiring New Boxed Warnings About Serious Risks and Death

August 31, 2016

Audience: Pharmacy, Internal Medicine, Psychiatry, Neurology, Family Practice. ISSUE: FDA review has found that the growing combined use of opioid medicines with benzodiazepines or other drugs that depress the central nervous system (CNS) has resulted in serious side effects, including slowed or difficult breathing and deaths.  Opioids are used to treat pain and cough; benzodiazepines are used to treat anxiety, ...

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Dietary Supplements by Ton Shen Health/Life Rising: Recall - Elevated Lead Levels

August 29, 2016

Audience: Consumer, Emergency Medicine. ISSUE: FDA is investigating DHZC-2 tablets by Ton Shen Health/Life Rising for lead and other hazardous material and is also investigating to see if other Life Rising products from this company may be similarly affected. The products were mostly sold in the Chicago metropolitan area in stores and online. FDA collected product samples at the Ton Shen Health/Life Rising retail ...

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Lamotrigine Orally Disintegrating Tablet 200 mg by Impax: Recall - Incorrect Labeling of Blister Cards

August 29, 2016

Audience: Pharmacy, Patient. ISSUE: Impax Laboratories, Inc. issued a voluntary nationwide retail level recall on August 19, 2016 for one lot of Lamotrigine Orally Disintegrating Tablet (ODT) 200 mg, NDC 0115-1529-08, Lot # 502240. The affected lot was distributed between June 13, 2016 and August 10, 2016 to wholesale distributors and retail pharmacies nationwide.  Unit-of-use blister packs (a 10 count blister card ...

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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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