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Showing 14281–14300 of 14360 results

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Loxitane Capsules 10mg (Watson) – Outdated Package Insert (2012)

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

FDAApr 17, 2012Nationwide• Watson Laboratories Inc

Loxapine Capsules 10mg (Watson) – Outdated Package Insert (2012)

Labeling: Incorrect or Missing Package Insert: An outdated version of a patient outsert was used when packaged.

FDAApr 17, 2012Nationwide• Watson Laboratories Inc

Multihance Injection (Bracco) – Sterility Concern (2012)

Lack of Assurance of Sterility; Product recalled due to displacement of the aluminum crimp cap during product usage.

Class IIModerate

FDAApr 16, 2012Nationwide• Bracco Diagnostics Inc

Multihance Injection (Bracco) – Short Fill Potential (2012)

Short Fill: The product is being recalled due to a potential underfill of the affected vials.

FDAApr 16, 2012Nationwide• Bracco Diagnostics Inc

Fosphenytoin Sodium Injection 500mg (West-ward) – Particulate Matter (2012)

Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.

Class IIModerate

FDAApr 13, 2012Nationwide• West-ward Pharmaceutical Corp.

Fosphenytoin Sodium Injection 100mg (West-ward) – Particulate Matter (2012)

Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.

Class IIModerate

FDAApr 13, 2012Nationwide• West-ward Pharmaceutical Corp.

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

Presence of Particulate Matter: A single visible particulate was observed in a retention sample bottles identified as stainless steel

Class IIModerate

FDAApr 11, 2012Nationwide• Hospira, Inc.

Carbon Dioxide Medical Gas (Airgas) – Nitrogen Dioxide Levels (2012)

Impurities/Degradation Products: Out Of Specification levels of nitrogen dioxide.

Class IIModerate

FDAApr 10, 2012AZ, CA, IN• Airgas Inc

Ciprofloxacin Tablets (Dr. Reddy's) – Mislabeled Bottles (2012)

Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets

Class IIModerate

FDAApr 9, 2012Nationwide• Dr. Reddy's Laboratories, Inc.

Amlodipine Besylate and Benazepril (Dr. Reddy's) – foreign tablet contamination (2012)

Adulterated Presence of Foreign Tablets: Dr. Reddy's Laboratories has received complaints of mislabeled bottles of Amlodipine Besylate and Benazepril Hydrochloride Capsules and Ciprofloxacin Tablets.

Class IIModerate

FDAApr 9, 2012Nationwide• Dr. Reddy's Laboratories, Inc.

Magnesium Sulfate Injection (Hospira) – superpotent drug (2012)

Superpotent (Single Ingredient) Drug: Above specification assay results for percentage of magnesium sulfate.

FDAApr 5, 2012Nationwide• Hospira, Inc.

Meloxicam Tablets (Apotex) – tablet thickness variation (2012)

Tablet Thickness: Recall was initiated due to the presence of one slightly oversized tablet in a bottle of the identified lot.

Class IIModerate

FDAApr 5, 2012Nationwide• Apotex Corp.

Mefloquine HCL Tablets (Teva) – weight inconsistency (2012)

Tablet Thickness: Product is being recalled due to the potential of being underweight or overweight.

Class IIModerate

FDAApr 2, 2012Nationwide• Teva Pharmaceuticals USA, Inc.

buPROPion Hydrochloride Tablets (McKesson) – Dissolution Failure (2012)

Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.

FDAMar 29, 2012Nationwide• McKesson Packaging Services

buPROPion Hydrochloride Tablets (McKesson) – Dissolution Failure (2012)

Failed USP Dissolution Test Requirements: Possible out-of-specification dissolution results at the 8 hour stability testing point.

FDAMar 29, 2012Nationwide• McKesson Packaging Services

Daytrana Patch (Noven Pharmaceuticals) – Delivery System Defect (2012)

Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value

Class IIModerate

FDAMar 22, 2012Nationwide• Noven Pharmaceuticals, Inc.

Warrior Whey Powder (Defense Nutrition) – Undeclared Soy (2012)

The products contain undeclared soy lecithin

FDAMar 22, 2012AL, AR, CO +20 more• Defense Nutrition

Organic Warrior Whey Powder (Defense Nutrition) – Undeclared Soy (2012)

The products contain undeclared soy lecithin

FDAMar 22, 2012AL, AR, CO +20 more• Defense Nutrition

Miracle Whey Protein Powder (Defense Nutrition) – Undeclared Soy (2012)

The products contain undeclared soy lecithin

FDAMar 22, 2012AL, AR, CO +20 more• Defense Nutrition

Metformin Tablets (Zydus Pharmaceuticals) – Foreign Substance (2012)

Presence of Foreign Substance(s): A product complaint was received from a pharmacist who discovered that several tablets displayed brown specks. The same complainant also reported that metal shaving like material was observed on the surface of one tablet.

Class IIModerate

FDAMar 14, 2012Nationwide• Zydus Pharmaceuticals USA Inc

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