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Showing 4101–4120 of 14370 results

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Prednisone Tablets (Lannett) - Label Mix Up (2020)

Labeling: Label Mix Up: bottle labeled to contain Prednisone Tablets, USP 2.5 mg actually contained Prednisone Tablets, USP 10 mg

Class IIModerate

FDAAug 10, 2020Nationwide• Lannett Company, Inc.

Sulfamethoxazole Tablets (Aurobindo) - Metal Wire Contamination (2020)

Presence of Foreign Substance: product complaints were received by the firm for the presence of metal wire in the tablet(s).

Class IIModerate

FDAAug 10, 2020Nationwide• Aurobindo Pharma USA Inc.

Elitek Injection (Sanofi-Aventis) - Stability Failure (2020)

Failed Stability Specifications: Out of Specification result for enzyme activity levels noted during routine stability testing.

Class IIModerate

FDAAug 10, 2020Nationwide• Sanofi-Aventis U.S. LLC

Vancomycin Ophthalmic Solution (Family Pharmacy) – sterility risk (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 6, 2020NC• Family Pharmacy of Statesville

Fentanyl Infusion (Family Pharmacy) - Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 6, 2020NC• Family Pharmacy of Statesville

Hydromorphone Infusion (Family Pharmacy) - Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 6, 2020NC• Family Pharmacy of Statesville

Hydromorphone Infusion Bags (Family Pharmacy) - Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 6, 2020NC• Family Pharmacy of Statesville

Morphine Sulfate Infusion (Family Pharmacy) - Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 6, 2020NC• Family Pharmacy of Statesville

Lorazepam Infusion (Family Pharmacy) - Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 6, 2020NC• Family Pharmacy of Statesville

Losartan Potassium Tablets (Hetero Labs) – tablet defect (2020)

Failed Tablet/Capsule Specification; complaint of bulging tablet

Class IIModerate

FDAAug 6, 2020Nationwide• Hetero Labs Limited (Unit V)

Trimix Injectable (Family Pharmacy) - Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 6, 2020NC• Family Pharmacy of Statesville

Methylcobalamin Injectable (Family Pharmacy) - Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 6, 2020NC• Family Pharmacy of Statesville

Ketamine Infusion (Family Pharmacy) - Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 6, 2020NC• Family Pharmacy of Statesville

Hydromorphone Infusion Bags (Family Pharmacy) - Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 6, 2020NC• Family Pharmacy of Statesville

Hydromorphone Infusion Bags (Family Pharmacy) - Sterility Concern (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 6, 2020NC• Family Pharmacy of Statesville

Trimix Injectable (Family Pharmacy) – sterility risk (2020)

Lack of Assurance of Sterility

Class IIModerate

FDAAug 6, 2020NC• Family Pharmacy of Statesville

Ear Pain MD Drops (Eosera) – manufacturing deviation (2020)

cGMP Deviations.

Class IIModerate

FDAAug 4, 2020Nationwide• Eosera, Inc.

Ear Pain MD Kids Drops (Eosera) – manufacturing deviation (2020)

cGMP Deviations.

Class IIModerate

FDAAug 4, 2020Nationwide• Eosera, Inc.

Nystatin Oral Suspension (PAI Holdings) – subpotent medication (2020)

Subpotent drug: Out of specification for assay at the 15-month test interval.

Class IIModerate

FDAAug 4, 2020Nationwide• PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Pain Relief Tablets (Ultra Seal) – stability specification failure (2020)

Failed Stability Specifications: Out-of-Specification (OOS) results for the Aspirin related compound Salicylic Acid was observed.

FDAAug 3, 2020IL, IN, TX• Ultra Seal Corporation

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