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Showing 13841–13860 of 14362 results

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Maxifed-G (TG United) – Dosage Incorrect (2013)

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

Class IIModerate

FDAJan 30, 2013FL, LA, MS +2 more• TG United, Inc.

AMBI 12.5 CPD/100GFN/30PSE (TG United) – Dosage Incorrect (2013)

CGMP Deviations: Products are underdosed or have an incorrect dosage regime.

Class IIModerate

FDAJan 30, 2013FL, LA, MS +2 more• TG United, Inc.

Lactated Ringer's Injection (Hospira) – Mold Contamination (2013)

Non-Sterility: Confirmed customer complaint of product contaminated with mold.

Class IHigh

FDAJan 25, 2013Nationwide• Hospira Inc.

Sodium Sulfacetamide Lotion (Mission Pharmacal) – Superpotent (2013)

Superpotent: Drug product active ingredients were formulated incorrectly (too high) with respect to the label strength.

FDAJan 23, 2013Nationwide• Mission Pharmacal Co

Terazosin Capsules (Teva) – Foreign Capsule Found (2013)

Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.

Class IIModerate

FDAJan 23, 2013Nationwide• Teva Pharmaceuticals USA, Inc.

Irinotecan Injection (Fresenius) – Crystallization Issue (2013)

Crystallization: Active pharmaceutical ingredient is precipitating in product solution.

Class IIModerate

FDAJan 22, 2013Nationwide• Fresenius Kabi USA LLC (FK USA)

Syeda Tablets (Sandoz) – Incorrect Tablet Imprint (2013)

Tablet/Capsule Imprinted with Wrong ID; a portion of the tablets could contain the incorrect debossing on one side of the tablet U2 instead of U3.

FDAJan 22, 2013Nationwide• Sandoz Incorporated

Medi-bolic Booster Injectable (RX3) – Manufacturing Deviation (2013)

CGMP Deviations: Pharmaceutical for injection was not manufactured according to Good Manufacturing Procedures.

Class IIModerate

FDAJan 22, 2013Nationwide• RX South LLC DBA RX3 Pharmacy

MET-Rx EXTREME NOS PUMPED Nitro-Punch (NBTY) – quality issue (2013)

The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage.

FDAJan 18, 2013Nationwide• NBTY Inc.

MET-Rx EXTREME NOS PUMPED Watermelon (NBTY) – quality issue (2013)

The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage.

FDAJan 18, 2013Nationwide• NBTY Inc.

MET-Rx EXTREME NOS PUMPED Double Berry (NBTY) – quality issue (2013)

The color, odor, and taste of the products are changing and do not meet the firm's high quality standards. This is an issue of commercial spoilage.

FDAJan 18, 2013Nationwide• NBTY Inc.

Mercuroclear Antiseptic First Aid (Humco) – Microbial Contamination (2013)

Microbial Contamination of Non-Sterile Product(s): The product has the potential to be contaminated with Bulkholderia gladioli.

Class IIModerate

FDAJan 17, 2013Nationwide• Humco Holding Group, Inc

Ventavis Inhalation Solution (Actelion) – Subpotent Drug (2013)

Subpotent Drug: OOS (out of specification) assay result at the 12 month stability time point.

FDAJan 16, 2013CA, VA• Actelion Pharmaceuticals U.S., Inc.

Carvedilol Tablets 12.5mg (Mylan) – Tablet Weight Issue (2013)

Failed Tablet/Capsule Specifications: Product exceeds specification for tablet weight and tablet thickness.

Class IIModerate

FDAJan 16, 2013Nationwide• Mylan Pharmaceuticals Inc.

Furosemide Injection (Hospira) – Sterility Concern (2013)

Lack of Assurance of Sterility; possible loose crimp applied to fliptop vial

Class IIModerate

FDAJan 10, 2013Nationwide• Hospira, Inc.

Glycopyrrolate Tablets (West-ward) – Subpotent Drug (2013)

Subpotent Drug

FDAJan 7, 2013OH• West-ward Pharmaceutical Corp.

Belladonna Alkaloids (West-ward) – Foreign Substance (2013)

Presence of Foreign Substance: Uncharacteristic blacks spots were found in tablets.

Class IIModerate

FDAJan 7, 2013Nationwide• West-ward Pharmaceutical Corp.

Reumofan Plus (Reumofan Plus USA) – Undeclared Ingredients (2013)

Undeclared Allergen

Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.

FDAJan 4, 2013Nationwide• Reumofan Plus USA

Bupropion XL Tablets (Actavis) – Dissolution Failure (2013)

Failed Dissolution Specifications; 8-hours for the 18-month stability testing point.

FDAJan 4, 2013Nationwide• Actavis Pharmaceuticals

Mitosol Ophthalmic Solution (Mobius) – Contamination Risk (2013)

Non-Sterility: one or more components of the kit have been found to be contaminated with yeast.

FDAJan 3, 2013Nationwide• Mobius Therapeutics LLC

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