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Showing 14021–14040 of 14362 results

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Prometh VC Plain (Actavis) – Stability Degradation (2012)

Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.

FDAAug 14, 2012Nationwide• Actavis Mid Atlantic LLC

Prometh VC with Codeine (Actavis) – Stability Degradation (2012)

Impurities/Degradation Products: Recalled lots do not meet room temperature stability specification for unknown degradant.

FDAAug 14, 2012Nationwide• Actavis Mid Atlantic LLC

Choletec Kit (Bracco) – Particulate Matter Risk (2012)

Presence of Particulate Matter; potential for charcoal particulates

Class IIILow

FDAAug 14, 2012Nationwide• Bracco Diagnostic Inc

intraKID (Drucker Labs) – Incorrect Vitamin B3 (2012)

After extensive testing and investigation, Drucker Labs has determined that an incorrect form of Vitamin B3, Nicotinic Acid, was used in the manufacturing of intraKID Lot 658. This nutrient may cause a temporary symptom in a small number of consumers. This symptom, commonly known as Niacin Flush, may include itching, redness, or warmth of the skin. This typically subsides within 15 20 minut

Class IIModerate

FDAAug 13, 2012Nationwide• Drucker Labs LP

Meal Replacement Shake (Atlas Operations) – Microbial contamination (2012)

Atlas Operations, Inc is recalling Meal Replacement foru Dietary Supplement, Lot R2-981-12, Exp. Date: 7/14 for possible microbial contamination.

Class IIModerate

FDAAug 7, 2012FL, IN, TX• Atlas Operations, Inc.

Doxazosin Tablets (Mylan) – Product Cross Contamination (2012)

Cross Contamination w/Other Products: During stability testing chromatographic review revealed extraneous peaks identified as acetaminophen and codeine.

Class IIModerate

FDAAug 7, 2012Nationwide• Mylan Pharmaceuticals Inc.

Propofol Injectable Emulsion (Hospira) – Visible Particulate (2012)

Presence of Particulate Matter: A single visible particulate was observed and confirmed in a sample bottle during retain inspection.

Class IIModerate

FDAAug 3, 2012Nationwide• Hospira Inc.

Citalopram 40mg Tablets (Dr. Reddy's) – Chemical Odor (2012)

Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.

Class IIModerate

FDAAug 1, 2012Nationwide• Dr. Reddy's Laboratories, Inc.

Citalopram 20mg Tablets (Dr. Reddy's) – Chemical Odor (2012)

Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.

Class IIModerate

FDAAug 1, 2012Nationwide• Dr. Reddy's Laboratories, Inc.

Citalopram 10mg Tablets (Dr. Reddy's) – Chemical Odor (2012)

Chemical Contamination: The product is being recalled due to complaints reporting a strong garlic odor or strong chemical smell.

Class IIModerate

FDAAug 1, 2012Nationwide• Dr. Reddy's Laboratories, Inc.

Shrimp Salad Sandwich (Whole Foods) – contamination risk (2012)

Whole Foods Market in Florida recalled certain fresh food items sold in the prepared foods department and one item in the seafood department as they could of been made using raw yellow onions processed by Gill Onions, LLC. Gill Onions, LLC initiated a recall on their product due to possible Listeria monocytogenes contamination.

FDAJul 27, 2012FL, IN• Ron Stockman Whole Foods

Levetiracetam Tablets (Mylan) – Foreign Tablet Presence (2012)

Adulterated Presence of Foreign Tablets: Pharmaceutical manufacturer may have distributed foreign tablets in bottles of Levetiracetam Tablets, USP 500 mg.

Class IIModerate

FDAJul 27, 2012KY• Mylan Pharmaceuticals Inc.

Ventolin HFA Inhaler (GlaxoSmithKline) – Improper Dose (2012)

Does Not Deliver Proper Metered Dose: Potential content of albuterol per dose is below specification.

Class IIModerate

FDAJul 26, 2012Nationwide• GlaxoSmithKline Inc

Topiramate Tablets 50mg (American Health Packaging) – label error (2012)

Labeling: Label Mix-Up: A typographical error in the product form on the carton label incorrectly lists the configuration as 30 "Capsules" (3 x 10) rather than "Tablets".

FDAJul 25, 2012Nationwide• American Health Packaging

Thyro-Tab 0.075mg (Lloyd Inc) – subpotent medication (2012)

Subpotent; 9-month stability interval

Class IIModerate

FDAJul 25, 2012Nationwide• Lloyd Inc. of Iowa

Levothroid 75mcg (Lloyd Inc) – subpotent medication (2012)

Subpotent; 9-month stability interval

Class IIModerate

FDAJul 25, 2012Nationwide• Lloyd Inc. of Iowa

Thyro-Tab 0.050mg (Lloyd Inc) – subpotent medication (2012)

Subpotent; 9-month stability interval

Class IIModerate

FDAJul 25, 2012Nationwide• Lloyd Inc. of Iowa

Levothroid 50 mcg Tablets (Lloyd Inc.) – Subpotent Medication (2012)

Subpotent; 9-month stability interval

Class IIModerate

FDAJul 25, 2012Nationwide• Lloyd Inc. of Iowa

OFIRMEV Acetaminophen Injection (Cadence) – Particulate Matter (2012)

Presence of Particulate Matter: The firm initiated the recall due to visible presence of particulate matter.

Class IIModerate

FDAJul 24, 2012Nationwide• Cadence Pharmaceuticals

Mercaptopurine Tablets (American Health Packaging) – dissolution failure (2012)

Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.

Class IIModerate

FDAJul 23, 2012Nationwide• American Health Packaging

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