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Showing 5261–5280 of 14370 results

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Methotrexate (Infusion Options) – Sterility Concern (2019)

Lack of Assurance of Sterility

Class IIModerate

FDAJun 12, 2019NY• Infusion Options, Inc.

Robafen DM (Preferred Pharmaceuticals) – Contamination Risk (2019)

CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

Class IIModerate

FDAJun 10, 2019CA, FL• Preferred Pharmaceuticals, Inc

Myorisan Capsules (Akorn) – Labeling Error (2019)

Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.

Class IIILow

FDAJun 7, 2019Nationwide• Akorn Inc

Losartan Potassium 50mg Tablets (Teva) – NMBA Impurity (2019)

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Class IIModerate

FDAJun 6, 2019Nationwide• Teva Pharmaceuticals USA

Losartan Potassium 100mg Tablets (Teva) – NMBA Impurity (2019)

CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.

Class IIModerate

FDAJun 6, 2019Nationwide• Teva Pharmaceuticals USA

Estradiol Vaginal Inserts (Glenmark) – Defective Delivery System (2019)

Defective Delivery System: Estradiol Vaginal Inserts USP plunger is not functioning properly.

Class IIModerate

FDAJun 3, 2019Nationwide• Glenmark Pharmaceuticals Inc., USA

Zyflo CR Tablets (Chiesi) – Dissolution Failure (2019)

Failed Dissolution Specifications: Out of specification result for dissolution.

Class IIModerate

FDAMay 31, 2019Nationwide• Chiesi USA, Inc.

Iron Elixir (Geritrex) – Microbial Contamination (2019)

cGMP Deviations: Products may have microbial contamination.

Class IIModerate

FDAMay 31, 2019Nationwide• Geritrex, LLC

Zileuton Extended-Release Tablets (Chiesi) – Dissolution Failure (2019)

Failed Dissolution Specifications: Out of specification result for dissolution.

Class IIModerate

FDAMay 31, 2019Nationwide• Chiesi USA, Inc.

Diocto Liquid Stool Softener (Geritrex) – Microbial Contamination (2019)

cGMP Deviations: Products may have microbial contamination.

Class IIModerate

FDAMay 31, 2019Nationwide• Geritrex, LLC

Iron Supplement Elixir (Geritrex) – Microbial Contamination (2019)

cGMP Deviations: Products may have microbial contamination.

Class IIModerate

FDAMay 31, 2019Nationwide• Geritrex, LLC

Ritussin DM Double Strength (Geritrex) – Microbial Contamination (2019)

cGMP Deviations: Products may have microbial contamination.

Class IIModerate

FDAMay 31, 2019Nationwide• Geritrex, LLC

Ritussin DM (Geritrex) – Microbial Contamination (2019)

cGMP Deviations: Products may have microbial contamination.

Class IIModerate

FDAMay 31, 2019Nationwide• Geritrex, LLC

Dioctyl Liquid Stool Softener (Geritrex) – Microbial Contamination (2019)

cGMP Deviations: Products may have microbial contamination.

Class IIModerate

FDAMay 31, 2019Nationwide• Geritrex, LLC

Diphenhydramine Oral Liquid (Geritrex) – Microbial Contamination (2019)

cGMP Deviations: Products may have microbial contamination.

Class IIModerate

FDAMay 31, 2019Nationwide• Geritrex, LLC

Trisodium Citrate 0.5% CRRT Solution (Surgery Pharmacy Services) – Sterility Risk (2019)

Lack of sterility assurance.

Class IIModerate

FDAMay 30, 2019GA, IN, TN• Surgery Pharmacy Services Inc

Memorial Central TPN (Surgery Pharmacy Services) – Sterility Risk (2019)

Lack of sterility assurance.

Class IIModerate

FDAMay 30, 2019GA, IN, TN• Surgery Pharmacy Services Inc

Acid Rain Fat Destroyer (Nexagen) – ingredient mislabeling (2019)

Product contains insufficient Higenamine and the label incorrectly declares Cayenne Pepper (CapsiMax) and Choline Bitartrate.

Class IIModerate

FDAMay 28, 2019AL, FL, GA +3 more• Nexagen, LLC

B-Complex Supplement (Pharm D Solutions) – sterility issue (2019)

Lack of Sterility Assurance.

Class IIModerate

FDAMay 23, 2019Nationwide• Pharm D Solutions, LLC

Human Chorionic Gonadotropin 5,000 IU (Pharm D Solutions) – Sterility Risk (2019)

Lack of Sterility Assurance.

Class IIModerate

FDAMay 23, 2019Nationwide• Pharm D Solutions, LLC

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