Skip to Content

FDA MedWatch Alerts

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

Pink Bikini and Shorts on The Beach Dietary Supplements by Lucy's Weight Loss System: Recall - Undeclared Drug Ingredient

January 29, 2016

[Posted 01/29/2016] AUDIENCE:Consumer ISSUE: Lucy's Weight Loss System of Arlington, TX, is voluntarily recalling all lots of Pink Bikini and Shorts on the Beach Capsules in all colors, 30 count (750MG per capsule) to the consumer level. Pink Bikini and Shorts on the Beach may contain an undeclared active pharmaceutical ingredient. FDA analysis of Pink Bikini (white capsules, blue capsules and gold capsules) and...

Read more

Crema Piel De Seda (Silky Skin Cream) by Viansilk: Consumer Warning - Risk of Mercury Poisoning

January 28, 2016

[Posted 01/28/2016] AUDIENCE: Consumer ISSUE: The Food and Drug Administration (FDA) is warning consumers not to purchase or use a skin whitening cream called “Crema Piel De Seda,” due to the risk of mercury poisoning. FDA laboratory analysis identified mercury in the product. Exposure to mercury can cause serious health problems, such as kidney and nervous system damage. Mercury can also interfere with brain dev...

Read more

Bentonite Me Baby – Bentonite Clay by Alikay Naturals: Consumer Warning - Risk of Lead Poisoning

January 28, 2016

Audience: Consumer. [Posted 01/28/2016] ISSUE: FDA is warning consumers not to use “Bentonite Me Baby” by Alikay Naturals because of a potential lead poisoning risk. FDA laboratory analysis of the product found elevated lead levels. Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. In children, chronic exposure to lead, even at low levels, is associated wit...

Read more

SPOTCHEM II Test Strips by Arkray: Class I Recall - Inaccurate Blood Sugar Readings

January 28, 2016

Audience: Risk Manager. [Posted 01/28/2016] ISSUE: Arkray is recalling the SPOTCHEM II Basic PANEL-1 Reagent Test Strip and SPOTCHEM II Glucose Reagent Test Strip because they may report falsely low blood glucose levels. Because the test strips are reporting falsely low blood glucose when the true levels are above 265 mg/dL, there is a risk that the health care provider would not diagnose hyperglycemia (high blood...

Read more

Baxter IV Solutions (Select Lots): Recall - Potential for Leaking Containers and Particulate Matter

January 27, 2016

Audience: Risk Manager, Nursing, Infectious Disease. 0.9% Sodium Chloride Injection, USP, 100mL in Mini-Bag Plus Container Metronidazole Injection, USP 500mg/100mL Clinimix E 5/15 (5% AA w/Electrolytes in 15% Dextrose w/Calcium) [Posted 01/27/2016] ISSUE: Baxter is voluntarily recalling four lots of intravenous (IV) solutions to the hospital/user level due to the potential for leaking containers and particulate...

Read more

Unexpired Sterile Human and Animal Compounded Products by Abbott's Compounding Pharmacy: Recall - Lack of Sterility Assurance

January 16, 2016

Audience: Patient, Pharmacy. [Posted 01/16/2016] ISSUE: Abbott's Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products due to concerns of lack of sterility assurance. All unexpired lots are subject to the recall. These include injectable medications, sterile solutions, eye drops, and eye ointments. All recalled products were distributed to patients, physician offices and...

Read more

Licorice Coughing Liquid OTC Cough Syrup by Ma Ying Long Pharmaceutical Group: CDER Alert - Contains Unidentified Morphine

January 16, 2016

Audience: Consumer, Pharmacy. [Posted 01/16/2016] ISSUE: The FDA is warning consumers not to use Licorice Coughing Liquid, a cough syrup product sold over-the-counter, because it contains unidentified morphine. The cough syrup’s labeling contains information written in English and Chinese. The product labeling does not identify the presence of morphine in English. With unidentified morphine,  consumers who are hy...

Read more

Children's Guaifenesin Grape Liquid and Guaifenesin DM Cherry Liquid by Perrigo Company: Recall - Potential Defect with Dosage Cup

January 13, 2016

Audience: Consumer. Including store brands: Sunmark   Rite-Aid   Topcare   Kroger   GoodSense   Dollar General Care One   CVS ISSUE: Perrigo Company announced that, following the recent recall of certain dosing cups by its supplier, it has initiated a voluntary product recall in the US to the retail level of 2 batches of its children's guaifenesin grape liquid (100mg/5 mL) and 3 batches of its child...

Read more

Multiple Products by R Thomas Marketing: Recall - Undeclared Drug Ingredient

January 9, 2016

Audience: Consumer. [Posted 01/09/2016] ISSUE: R Thomas Marketing LLC is voluntarily recalling all lots of the following products to the consumer level: Black Ant: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules total) Herb Viagra: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules) Real Skill: BIG BOX (20 small boxes / 4 capsules per box / 80 capsules) Stree Overlord: BIG BOX (20 small...

Read more

L.G Compounded Asafoetida Powder by Shakti Group: Recall - Potential Contamination with Salmonella

January 8, 2016

Audience: Consumer. ISSUE: Shakti Group USA LLC is recalling 50 gm and 100 gm sizes of L.G Compounded Asafoetida Powder, both coded with Lot Number: 2323 because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. The recall is a result of sampling conducted by...

Read more

Magnesium Sulfate in Water for Injection by Hospira: Recall - Incorrect Barcode Labeling on the Primary Container

January 6, 2016

Audience: Pharmacy. ISSUE: Hospira, Inc. announced a voluntary recall of one lot of MAGNESIUM SULFATE IN WATER FOR INJECTION (0.325 mEq Mg**/mL) 40 mg/mL 2g total, 50 mL (NDC: 0409-6729-24, Lot 53-113-JT, Expiry 1NOV2016) to the user level due to a confirmed customer report of an incorrect barcode on the primary bag labeling. The product has a barcode identifying the product contents on both the overwrap and on the...

Read more

Baxter IV Solutions: Recall - Potential Presence of Particulate Matter

January 5, 2016

Audience: Pharmacy. Includes: 0.9% Sodium Chloride Injection, USP, 250 mL VIAFLEX Plastic Container 70% Dextrose Injection (2000 mL) USP ISSUE: Baxter International Inc. announced a voluntarily recall of two lots of intravenous (IV) solutions to the hospital/end user level due to the potential presence of particulate matter. The particulate matter in each case was determined to be an insect and was identified...

Read more

Noxafil (posaconazole): Drug Safety Communication - Dosing Errors when Switching between Different Oral Formulations; Label Changes Approved

January 4, 2016

Audience: Internal Medicine, Infectious Disease. ISSUE: The FDA is cautioning that differences in dosing regimens between the two oral formulations of the antifungal Noxafil (posaconazole) have resulted in dosing errors.  To help prevent additional medication errors, the drug labels were revised to indicate that the two oral formulations cannot be directly substituted for each other but require a change in dose.  D...

Read more

4mg Norepinephrine Bitartrate (16mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 8mg Norepinephrine Bitartrate (32mcg/mL) Added to 0.9% Sodium Chloride in 250mL Viaflex Bag by Pharmedium: Recall - Discoloration

December 31, 2015

Audience: Pharmacy, Critical Care Medicine. ISSUE: PharMEDium Services, LLC is voluntarily recalling 29 lots of 4mg Norepinephrine Bitartrate (16mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag and 3 lots of 8mg Norepinephrine Bitartrate (32mcg/mL) added to 0.9% Sodium Chloride in 250mL Viaflex Bag distributed to hospital customers. They have received complaints from hospitals for products that have been...

Read more

Apexxx by Nuway Distributors : Recall - Undeclared Drug Ingredient

December 23, 2015

Audience: Consumer. [Posted 12/23/2015] ISSUE: Nuway Distributors llc is voluntarily recalling all lots of Apexxx tablets to the consumer level. FDA analysis found Apexxx to contain amounts of the PDE-5 Inhibitor, sildenafil, which is the active ingredient in an FDA-approved drug for erectile dysfunction (ED) making this tainted dietary supplement and unapproved drug. Sildenafil is not listed on the product...

Read more

La' Trim Plus, Jenesis and Oasis by BeeXtreme: Recall - Undeclared Drug Ingredients

December 23, 2015

Audience: Consumer. [Posted 12/23/2015] ISSUE: BeeXtreme LLC is recalling all lots of La' Trim Plus, Jenesis and Oasis products from the market. Recent Analysis by the Food and Drug Administration has found undeclared Sibutramine and Phenolphthalein in the Dietary Supplement "La' Trim Plus", “Oasis”, and “Jenesis”.  The recall includes all lots and expiration dates. BACKGROUND: Sibutramine and Phenolphthalein pos...

Read more

Various Products Distributed for Weight Loss by Bee Extremely Amazed: Recall - Undeclared Drug Ingredients

December 23, 2015

Audience: Consumer. [Posted 12/23/2015] ISSUE: Bee Extremely Amazed LLC, Jewett, OH is voluntarily recalling various products marketed for weight loss to the consumer level due to findings of undeclared drug ingredients including sibutramine and/or phenolphthalein.  Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially increase blood ...

Read more

Smart Lipo: Recall - Undeclared Drug Ingredients

December 18, 2015

Audience: Consumer. [Posted 12/18/2015] ISSUE: SmartLipo365 is voluntarily recalling all lots of Smart Lipo (800, 900, 950 mg) capsules to the consumer level. FDA's analysis found the Smart Lipo products to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These...

Read more

Rosiglitazone-containing Diabetes Medicines: Drug Safety Communication - FDA Eliminates the Risk Evaluation and Mitigation Strategy (REMS)

December 16, 2015

Audience: Family Care, Endocrinology, Cardiology. ISSUE: FDA is eliminating the Risk Evaluation and Mitigation Strategy (REMS) for rosiglitazone-containing type 2 diabetes medicines, which are approved as Avandia, Avandamet, Avandaryl, and generics. The REMS is no longer necessary to ensure that the benefits of rosiglitazone medicines outweigh their risks. In 2013, FDA required removal of the prescribing and...

Read more

Baclofen Active Pharmaceutical Ingredient from Taizhou Xinyou Pharmaceutical and Chemical: FDA Statement - FDA Warns of Potential Contamination

December 10, 2015

Audience: Health Professional, Anesthesiology, Pain Management, Neurology, Pharmacy. [Posted 12/09/2015] ISSUE: FDA is alerting drug compounders that certain lots of baclofen active pharmaceutical ingredient (API) manufactured by Taizhou Xinyou Pharmaceutical & Chemical Co., Limited (Taizhou) Taizhou City, Zhejiang Province, China, may be at risk for contamination with particulates and should not be used to...

Read more
Older articles
Hide