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Showing 14621–14640 of 15081 results

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Dextroamphetamine Capsules (Amedra) - dissolution failure (2012)

Failed Dissolution Specifications: The affected lots may not meet the specifications for dissolution over the product shelf life.

Class IIModerate

FDADec 4, 2012Nationwide• Amedra Pharmaceuticals LLC

Lisinopril Hydrochlorothiazide (West-ward) - steel particulates (2012)

Presence of Foreign Substance: Reports of gray smudges identified as minute stainless steel particulates were found in the recalled tablets.

Class IIModerate

FDANov 30, 2012Nationwide• West-ward Pharmaceutical Corp.

Ethambutol Tablets (West-ward) - tablet discoloration (2012)

Discoloration: Ethambutol Tablets USP 400 mg have tablets cores that may be discolored.

Class IIModerate

FDANov 30, 2012GA• West-ward Pharmaceutical Corp.

Carisoprodol Tablets (West-ward) - DEA schedule change (2012)

Labeling: Not elsewhere classified: On 12/12/11, DEA published a final rule in the Federal Register making this product a schedule IV (C-IV)controlled substance. This product is being recalled because this controlled product was not relabeled with the required "C-IV" imprint on the label for products distributed after the 06/11/12 deadline.

FDANov 30, 2012Nationwide• West-ward Pharmaceutical Corp.

TORISEL Injection (Pfizer) – sterility risk (2012)

Lack of Assurance of Sterility; potential that a low level of endotoxins may be present in the diluent vials.

FDANov 26, 2012Nationwide• Pfizer Inc.

Derma-Smoothe/FS Scalp Oil (Hill) – subpotent medication (2012)

Subpotent; 22 month stability timepoint

FDANov 21, 2012Nationwide• Hill Dermaceuticals, Inc.

Nalbuphine HCl Injection (Hospira) – sterility concern (2012)

Lack of Assurance of Sterility: Complains of a loose crimp applied to the fliptop vial; and a missing stopper and flip cap were received and therefore sterility cannot be assured.

Class IIModerate

FDANov 21, 2012Nationwide• Hospira, Inc.

Isovue-370 Injection (Bracco) – particulate matter (2012)

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

FDANov 21, 2012Nationwide• Bracco Diagnostic Inc

Derma-Smoothe/FS Body Oil (Hill) – subpotent medication (2012)

Subpotent; 12 month stability timepoint

FDANov 21, 2012Nationwide• Hill Dermaceuticals, Inc.

Fluorouracil Topical Cream (Taro) – stability issues (2012)

Product Lacks Stability: Out-of-specification (OOS) results were observed for assay and description in retain samples.

Class IIModerate

FDANov 21, 2012Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Isovue-300 Injection (Bracco) – particulate matter (2012)

Presence of Particulate Matter; fibers identified as cellulose and polyvinyl

FDANov 21, 2012Nationwide• Bracco Diagnostic Inc

Propranolol Extended-release Capsules (Upsher) – dissolution failure (2012)

Failed Dissolution Test Requirements

Class IIModerate

FDANov 20, 2012FL, NJ• Upsher Smith Laboratories, Inc.

Propofol Injectable Emulsion (Hospira) – particulate matter (2012)

Presence of Particulate Matter: Visible particulate and particulate embedded in vials were observed during retain inspection.

Class IIModerate

FDANov 15, 2012Nationwide• Hospira Inc.

Atorvastatin Tablets 10mg (Ranbaxy) – glass particulates (2012)

Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.

Class IIModerate

FDANov 9, 2012Nationwide• Ranbaxy Inc.

Atorvastatin Tablets 40mg (Ranbaxy) – glass particulates (2012)

Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.

Class IIModerate

FDANov 9, 2012Nationwide• Ranbaxy Inc.

Atorvastatin Tablets 20mg (Ranbaxy) – glass particulates (2012)

Presence of Particulate Matter: Certain batches of Atorvastatin tablets 10 mg, 20 mg and 40 mg may contain small glass particulates.

Class IIModerate

FDANov 9, 2012Nationwide• Ranbaxy Inc.

Carboplatin Injection 450mg (Hospira) – crystallization risk (2012)

Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.

FDANov 8, 2012Nationwide• Hospira Inc.

Carboplatin Injection 600mg (Hospira) – crystallization risk (2012)

Crystallization: Product is being recalled due to visible particulates identified during a retain sample inspection. Findings have identified the particles as Carboplatin crystals.

FDANov 8, 2012Nationwide• Hospira Inc.

Clinical LIVE Immune Support (Reaction Nutrition) – undeclared dairy (2012)

Undeclared Allergen

The product contained an undeclared allergen, Colostrum, which is considered a dairy product and therefore requires an allergen statement on the label.

FDANov 7, 2012Nationwide• Reaction Nutrition LLC

VIVITROL Injection (Alkermes) – sterility risk (2012)

Lack of Assurance of Sterility: Product did not meet the criteria for container closure integrity testing during routine 24 month stability testing.

Class IIModerate

FDANov 6, 2012Nationwide• Alkermes, Inc.

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