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Showing 14421–14440 of 15081 results

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Levoxyl (Pfizer) – Odor Contamination (2013)

Chemical contamination: emission of strong odor after package was opened.

Class IIModerate

FDAMar 28, 2013Nationwide• Pfizer Inc.

Levoxyl (Pfizer) – Odor Contamination (2013)

Chemical contamination: emission of strong odor after package was opened.

Class IIModerate

FDAMar 28, 2013Nationwide• Pfizer Inc.

Levoxyl (Pfizer) – Odor Contamination (2013)

Chemical contamination: emission of strong odor after package was opened.

Class IIModerate

FDAMar 28, 2013Nationwide• Pfizer Inc.

Levoxyl (Pfizer) – Odor Contamination (2013)

Chemical contamination: emission of strong odor after package was opened.

Class IIModerate

FDAMar 28, 2013Nationwide• Pfizer Inc.

Levoxyl (Pfizer) – Odor Contamination (2013)

Chemical contamination: emission of strong odor after package was opened

Class IIModerate

FDAMar 28, 2013Nationwide• Pfizer Inc.

All One Original Formula Vitamin Powder (All One) - mislabeled dairy (2013)

Product label misprinted to include claim of "No Dairy", even though milk is present in an ingredient (calcium caseinate). "Certified Vegan" is also claimed on the product label. The side panel discusses the presence of milk in the product.

Class IIModerate

FDAMar 28, 2013Nationwide• All One, Inc.

Methylcobalamin Injection (NuVision) – Sterility Concerns (2013)

Lack of Assurance of Sterility; reports of adverse events after injection

Class IIModerate

FDAMar 28, 2013FL, MO, UT +1 more• NuVision Pharmacy, Inc.

Levoxyl (Pfizer) – Odor Contamination (2013)

Chemical contamination: emission of strong odor after package was opened..

Class IIModerate

FDAMar 28, 2013Nationwide• Pfizer Inc.

Levoxyl (Pfizer) – Odor Contamination (2013)

Chemical contamination: emission of strong odor after package was opened..

Class IIModerate

FDAMar 28, 2013Nationwide• Pfizer Inc.

All One Active Senior Vitamin Powder (All One) - mislabeled dairy (2013)

Product label misprinted to include claim of "No Dairy", even though milk is present in an ingredient (whey protein isolate). "Certified Vegan" is also claimed on the product label. The Supplement Facts panel and side panel discusses the presence of milk in the product.

Class IIModerate

FDAMar 28, 2013Nationwide• All One, Inc.

Lorazepam (Legacy) – Labeling Error (2013)

Labeling: Incorrect or Missing Lot and/or Exp Date: Lorazepam Lot # L-04009

FDAMar 27, 2013IN• Legacy Pharmaceutical Packaging LLC

Hydroxyprogesterone CAPR.(G.S.) (Pallimed Solutions) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAMar 25, 2013Nationwide• Pallimed Solutions

Atropine Injection (Pallimed Solutions) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAMar 25, 2013Nationwide• Pallimed Solutions

Nandrolone Decanoate Injectable (Pallimed Solutions) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAMar 25, 2013Nationwide• Pallimed Solutions

Quadmix Injection (Pallimed) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAMar 25, 2013Nationwide• Pallimed Solutions

Trimix Injection (Pallimed Solutions) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAMar 25, 2013Nationwide• Pallimed Solutions

Dexamethasone PF (Pallimed Solutions) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAMar 25, 2013Nationwide• Pallimed Solutions

MIC with B6 and B12 (Pallimed Solutions) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAMar 25, 2013Nationwide• Pallimed Solutions

Alprostadil IN NS Injection (Pallimed Solutions) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAMar 25, 2013Nationwide• Pallimed Solutions

Cidofovir Opthalmic Solution (Pallimed Solutions) – Sterility Concerns (2013)

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Class IIModerate

FDAMar 25, 2013Nationwide• Pallimed Solutions

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