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Showing 3221–3240 of 3363 results

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Enalapril Maleate Tablets (Apace) – Labeling Error (2012)

Labeling Illegible: Some bottles labels have incomplete NDC numbers and missing strength.

FDASep 4, 2012Nationwide• Apace KY LLC

IQF PND Shrimp (Chang Jiang) – Unapproved Antibiotic (2012)

Chang Jiang Seafood CA Inc. is recalling Frozen Shrimp because it contains nitrofuran which is an unapproved antibiotic.

FDAAug 27, 2012AZ, CA, UT• Chang Jiang Seafood Ca Inc

Venlafaxine ER (Stat Rx USA) – Labeling error (2012)

Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."

Class IIILow

FDAAug 23, 2012GA, TN• Stat Rx USA

Novarel Chorionic Gonadotropin (Ferring Pharmaceuticals) – Labeling omission (2012)

Labeling; incorrect or missing insert; Warnings portion of the Package Insert is missing the warning statement: Anaphylaxis has been reported with urinary-derived hCG products.

FDAAug 23, 2012Nationwide• Ferring Pharmaceuticals Inc

Major Oral Peroxide (Axcentria) – Unstable Expiration (2012)

Stability data does not support expiration date: Stability data indicates the Carbamide Peroxide will degrade below acceptable levels within the 24-month expiration date printed on the packaging.

FDAAug 17, 2012MI• Axcentria Pharmaceuticals LLC

Mushrooms (Meijer) – Sodium labeling issue (2012)

The sodium in the product is above the declared value of the sodium stated on the label.

FDAAug 16, 2012IL, IN, KY +2 more• Meijer Distribution, Inc

Capex Shampoo (Galderma) – Subpotent Medication (2012)

Subpotent; fluocinolone acetonide.

FDAAug 15, 2012Nationwide• Galderma Laboratories, L.P.

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

Presence of Particulate Matter; potential for charcoal particulates

FDAAug 14, 2012Nationwide• Bracco Diagnostic Inc

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

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

CLIF Bar White Chocolate Macadamia (Clif Bar) – undeclared coconut (2012)

Undeclared Allergen

The product contains undeclared Coconut in the ingredient statement. The Coconut Chocolate Chip bars were inadvertently placed in White Chocolate Macadamia CLIF Bar wrappers and these mislabeled bars were placed inside correctly labeled Coconut Chocolate Chip CLIF Bar boxes.

FDAJul 30, 2012IN• Clif Bar And Company

CLIF Bar Coconut Chocolate Chip (Clif Bar) – undeclared coconut (2012)

Undeclared Allergen

The product contains undeclared Coconut in the ingredient statement. The Coconut Chocolate Chip bars were inadvertently placed in White Chocolate Macadamia CLIF Bar wrappers and these mislabeled bars were placed inside correctly labeled Coconut Chocolate Chip CLIF Bar boxes.

FDAJul 30, 2012IN• Clif Bar And Company

Thallous Chloride Injection (Mallinckrodt) – Mislabeled Containers (2012)

Labeling: Correct Labeled Product Miscart/Mispack: labels on outer containers do not match labels on vials (the correct label)

FDAJul 30, 2012AZ, CA, CT +8 more• Mallinckrodt Inc

Oasis Mouthwash (Natural Essentials) – Bacterial Contamination (2012)

Microbial Contamination of a Non-Sterile Products: Three product lots are contaminated with Burkholderia cepacia.

FDAJul 27, 2012Nationwide• Natural Essentials 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

Tizanidine 4mg Tablets (Stat Rx USA) – Label Mix-Up (2012)

Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.

FDAJul 23, 2012Nationwide• Stat Rx USA

Bubble Gum Ice Cream (Cass Clay Creamery) – Undeclared Colors (2012)

Undeclared Allergen

Cass-Clay Creamery is voluntarily recalling a number of ice cream products because they may contain undeclared red 40, Blue 1, and Blue 2.

FDAJul 20, 2012AZ, KS, MN +2 more• Cass Clay Creamery AMPI Fargo Division

Ketoconazole Cream 2% (Fougera) – Specification Failure (2012)

Failed Impurities/Degradation Specifications: Ketoconazole Cream 2% is the subject of a voluntary drug recall by Fougera due to an Out Of Specification result for an unknown degradant product

FDAJul 18, 2012Nationwide• Fougera Pharmaceuticals Inc.

Infants' Mapap Acetaminophen (Axcentria) – incorrect expiration (2012)

Labeling; labeled with incorrect EXP Date; Incorrect expiration date printed on the outer packaging. Package incorrectly states 5/2014 should correctly state 4/2014

FDAJul 12, 2012MI• Axcentria Pharmaceuticals LLC

Hydroxyzine Hydrochloride Oral Solution (Vintage Pharmaceuticals) – impurity risk (2012)

Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.

FDAJul 6, 2012Nationwide• Vintage Pharmaceuticals LLC DBA Qualitest Pharmaceuticals

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