Skip to Content

FDA MedWatch Alerts

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

Potassium Phosphate and Succinylcholine Chloride by PharMEDium Services: Recall - Lack of Sterility Assurance

June 27, 2017

Audience: Pharmacy. [Posted 06/27/2017] ISSUE: PharMEDium Services is conducting a limited, voluntary recall due to Hospira Inc.’s (“Hospira”) June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance. The products being recalled by PharMEDium Services were compounded using certain Hospira prod...

Read more

Succinylcholine Chloride 20mg/mL 5mL Syringe by Fagron Sterile Services: Recall - Potential Lack Of Sterility Assurance

June 23, 2017

Audience: Pharmacy, Critical Care Medicine. ISSUE: Fagron Sterile Services is voluntarily recalling three (3) lots of Succinylcholine Chloride 20mg/mL 5mL syringe to the hospital/clinic level. The secondary recall of product manufactured by Hospira Inc., a Pfizer company, and repacked by Fagron Sterile Services, is due to microbial growth detected during a routine simulation of Hospira’s manufacturing process, which ...

Read more

Potassium Phosphate and Succinylcholine by Advanced Pharma: Recall - Potential Lack of Sterility Assurance

June 22, 2017

Audience: Pharmacy. ISSUE: Advanced Pharma, Inc. d/b/a Avella of Houston is conducting a limited, voluntary recall due to Hospira Inc.’s June 15, 2017 recall announcement that microbial growth was detected during a routine simulation of the manufacturing process and therefore there was a lack of sterility assurance. The products being recalled by Advanced Pharma were repackaged and/or compounded at its Houston, T...

Read more

Clindamycin Injection ADD-Vantage Vials by Alvogen: Recall - Lack of Sterility Assurance

June 17, 2017

Audience: Pharmacy, Health Professional, Infectious Disease. ISSUE: Alvogen is voluntarily recalling seven lots of Clindamycin Injection USP ADD-Vantage Vials to the hospital/retail level due to microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the product. Clindamycin Injection is manufactured for Alvogen by Hospira...

Read more

Sodium Bicarbonate Injection 8.4 Percent USP, Neut (Sodium Bicarbonate 4 Percent Additive Solution), Quelicin (Succinylcholine Chloride Injection USP), and Potassium Phosphates Injection by Hospira: Recall - Potential For Lack Of Sterility Assurance

June 15, 2017

Audience: Pharmacy, Critical Care Medicine, Nursing. ISSUE: Hospira, Inc., a Pfizer company, is voluntarily recalling 42 lots of 8.4% Sodium Bicarbonate Injection, USP, 50 mL vials, 5 lots of NeutTM (Sodium Bicarbonate 4% additive solution) 5 mL vials, 5 lots of QUELICINTM (Succinylcholine Chloride Injection, USP) 200 mg/10 mL vials and 7 lots of Potassium Phosphates Injection, USP, 45 mM vials to the...

Read more

Unexpired Nitroglycerin Injection in 5 Percent Dextrose USP by Advanced Pharma in Houston: Recall - Sub Potency

June 15, 2017

Audience: Pharmacy, Cardiology, Nursing. ISSUE: Advanced Pharma, Inc. d/b/a Avella of Houston (“Advanced Pharma”) is voluntarily recalling all unexpired lots of Nitroglycerin products that were produced at Advanced Pharma’s Houston location between March 3, 2017 and May 31, 2017 to the hospital/user level. The recall is being issued based on laboratory test results indicating a lower than expected potency on certain ...

Read more

Paliperidone Extended-Release Tablets 3mg by Teva Pharmaceuticals: Recall - Dissolution Test Failure

June 15, 2017

Audience: Pharmacy, Psychiatry, Patient. ISSUE: Teva Pharmaceuticals USA, Inc. (Teva) initiated a voluntary recall to retail-level on 05/31/2017 for one lot of Paliperidone Extended-Release Tablets, 3mg, 90 count bottles, lot 1160682A, expiration 6/2018, NDC 0591-3693-19, that was distributed under the Actavis Pharma Inc. label. In coordination with FDA, Teva is extending this recall to the consumer/user l...

Read more

Topical Products by Phillips Company: Recall - Due to Concerns of Manufacturing Practices

June 14, 2017

Audience: Pharmacy, Health Professional, Consumers. ISSUE: Phillips Company is voluntarily recalling all lots of Tetrastem, Diabecline, Tetracycline-ABC, VenomX, Acneen, StaphWash, StringMed, NoPain and LidoMed distributed by Phillips Company, with business offices located in Sun City, Arizona, to the retail level. The products are being recalled after an FDA inspection found significant manufacturing practices that...

Read more

Eliquis (apixaban) 5 mg tablets: Recall One Lot- Bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5 mg tablets

June 13, 2017

Audience: Cardiology, Pharmacy. ISSUE: Bristol-Myers Squibb Company is voluntarily recalling one lot (#HN0063) of Eliquis 5 mg tablets to the consumer level. This lot was distributed nationwide in the U.S. to wholesalers and retail pharmacies in February 2017. Bristol-Myers Squibb is taking this precautionary measure based on a customer complaint that a bottle labeled as Eliquis 5 mg was found to contain Eliquis 2.5...

Read more

Mibelas 24 Fe Chewable Tablets by Lupin Pharmaceuticals Inc.: Recall - Out of Sequence Tablets and Missing Expiry/Lot Information

May 29, 2017

Audience: Family Practice, Health Professional, Consumers. ISSUE: Lupin Pharmaceuticals Inc. announced a recall of lot L600518, Exp 05/18 of Mibelas 24 Fe (Norethindrone Acetate and Ethinyl Estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) Tablets at the consumer level. A confirmed market complaint indicated a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the ...

Read more

Brilinta (ticagrelor) 90 mg tablets, 8-count Physician Sample Bottles: Recall of Lot # JB5047 - Due to Report of Another Medicine in One Bottle

May 26, 2017

Audience: Family Practice, Health Professional, Consumers. ISSUE: AstraZeneca is notifying physicians and consumers that it is voluntarily recalling one lot of professional (physician) sample bottles containing eight tablets of Brilinta (ticagrelor) 90mg tablets as a precautionary measure. This voluntary recall follows a report that a professional sample bottle containing eight tablets of Brilinta 90mg also...

Read more

Caverflo Natural Herbal Coffee: Recall - Presence of Undeclared Active Pharmaceutical Ingredients

May 26, 2017

Audience: Family Practice, Consumer. ISSUE: Caverflo.com is voluntarily recalling all lots of Caverflo Natural Herbal Coffee, 25 grams to the consumer level. FDA laboratory analysis confirmed the presence of Sildenafil and Tadalafil which are the active ingredients in two FDA-approved prescription drugs used for the treatment of erectile dysfunction (ED). Caverflo.com has received a report of an individual death...

Read more

Al-Er-G Capsules by MusclMasster: Recall - Contains Banned Substance Ephedra

May 25, 2017

Audience: Consumer. ISSUE: MusclMasster, LLC is recalling all bottles of Al-Er-G Capsules. During a recent FDA inspection, it was discovered that this product contained Ephedra Herb, an FDA banned ingredient. Dietary supplements containing ephedrine alkaloids pose a risk of serious adverse events, including heart attack, stroke, and death, and that these risks are unreasonable in light of any benefits that may...

Read more

Tri-Ton by Dynamic Technical Formulations, LLC: Recall - Contains Andarine and Ostarine Drug Ingredients

May 22, 2017

Audience: Consumer. ISSUE: Dynamic Technical Formulations LLC. is voluntarily recalling all lots of Tri-Ton. This product was sold in 90 count bottles as a dietary supplement and includes all lot number and expiration dates of the product. FDA lab analysis of Tri-Ton was found to contain andarine and ostarine which are selective androgen receptor modulators (SARMs) that are considered unapproved drugs and anabolic...

Read more

Gadolinium-based Contrast Agents for Magnetic Resonance Imaging (MRI): Drug Safety Communication - No Harmful Effects Identified With Brain Retention

May 22, 2017

Audience: Radiology. ISSUE: An FDA review to date has not identified adverse health effects from gadolinium retained in the brain after the use of gadolinium-based contrast agents (GBCAs) for magnetic resonance imaging (MRI). Including: Ablavar (gadofosveset trisodium) Dotarem (gadoterate meglumine) Eovist (gadoxetate disodium) Gadavist (gadobutrol) Magnevist (gadopentetate dimeglumine) MultiHance (gadobenate...

Read more

LeadCare Testing Systems (with Blood Obtained from a Vein) by Magellan Diagnostics: FDA Safety Communication - Risk of Inaccurate Results

May 17, 2017

Audience: Pediatrics, Risk Manager, Laboratory, Family Medicine. ISSUE: The U.S. Food and Drug Administration and Centers for Disease Control and Prevention are warning Americans that certain lead tests manufactured by Magellan Diagnostics may provide inaccurate results for some children and adults in the United States. Falsely lower test results may lead to improper patient management and treatment for lead...

Read more

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

May 16, 2017

Audience: Internal Medicine, Family Practice, Pharmacy, Patient. ISSUE: Based on new data from two large clinical trials, the FDA has concluded that the type 2 diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR) causes an increased risk of leg and foot amputations. FDA is requiring new warnings, including the most prominent Boxed Warning, to be added to the canagliflozin drug labels to describe this...

Read more

GEC Laxoplex Dietary Supplement Capsules by Genetic Edge Compounds: Recall - Presence of Anabolic Steroids

May 8, 2017

Audience: Consumer. [Posted 05/08/2017] ISSUE: Genetic Edge Compounds recalled all lot codes of GEC Laxoplex dietary supplement capsules distributed between February 2, 2015- May 2, 2017 to the retail level and consumer level. FDA analysis found GEC Laxoplex to be tainted with anabolic steroids and steroid like substances. The presence of these anabolic steroids and steroid like substances in GEC Laxoplex renders...

Read more

General Anesthetic and Sedation Drugs: Drug Safety Communication - FDA Approves Label Changes for Use in Young Children

April 27, 2017

Audience: Consumer, Surgery, Anesthesiology. ISSUE: FDA has approved previously announced label changes regarding the use of general anesthetic and sedation medicines in children younger than 3 years. These changes include: A new Warning stating that exposure to these medicines for lengthy periods of time or over multiple surgeries or procedures may negatively affect brain development in children younger than 3...

Read more

Illegal Cancer Treatments: FDA Warning - Fraudulent Claims of Diagnosis, Treatment, Prevention or Cure

April 25, 2017

Audience: Oncology, Patient, Consumer. ISSUE: FDA issued warning letters addressed to 14 U.S.-based companies illegally selling more than 65 products that fraudulently claim to prevent, diagnose, treat or cure cancer. It is a violation of the Federal Food, Drug and Cosmetic Act to market and sell products that claim to prevent, diagnose, treat, mitigate or cure diseases without first demonstrating to the FDA that...

Read more
Older articles

FDA MedWatch Alerts Archive

Hide