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Showing 9961–9980 of 14370 results

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Bi-Est Hormone Drops (South Coast) – penicillin contamination (2015)

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Class IIModerate

FDAApr 23, 2015Nationwide• South Coast Specialty Compounding, Inc.

Leucovorin Calcium Capsules (South Coast) – penicillin contamination (2015)

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Class IIModerate

FDAApr 23, 2015Nationwide• South Coast Specialty Compounding, Inc.

Methyl Folate Injection (South Coast) – penicillin contamination (2015)

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Class IIModerate

FDAApr 23, 2015Nationwide• South Coast Specialty Compounding, Inc.

Cytarabine Injection (Mylan) – particulate matter (2015)

Presence of Particulate Matter

FDAApr 23, 2015Nationwide• Mylan Institutional LLC

Tri-Est Progesterone Capsules (South Coast) – penicillin contamination (2015)

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Class IIModerate

FDAApr 23, 2015Nationwide• South Coast Specialty Compounding, Inc.

Meloxicam Capsules (South Coast) – penicillin contamination (2015)

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Class IIModerate

FDAApr 23, 2015Nationwide• South Coast Specialty Compounding, Inc.

Artesunate Injection (South Coast) – penicillin contamination (2015)

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Class IIModerate

FDAApr 23, 2015Nationwide• South Coast Specialty Compounding, Inc.

Bi-Est Progesterone Capsules (South Coast) – penicillin contamination (2015)

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Class IIModerate

FDAApr 23, 2015Nationwide• South Coast Specialty Compounding, Inc.

Estriol Estradiol Cream (South Coast) – penicillin contamination (2015)

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Class IIModerate

FDAApr 23, 2015Nationwide• South Coast Specialty Compounding, Inc.

Estradiol Cream (South Coast) – penicillin contamination (2015)

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Class IIModerate

FDAApr 23, 2015Nationwide• South Coast Specialty Compounding, Inc.

Bi-Est Testosterone Cream (South Coast) – penicillin contamination (2015)

Penicillin Cross Contamination: Multiple finished products potentially contaminated with penicillin.

Class IIModerate

FDAApr 23, 2015Nationwide• South Coast Specialty Compounding, Inc.

Lansoprazole Capsules (Wockhardt) – Quality Control Issues (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Famotodine 40mg Tablets (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Metoprolol Succinate 50mg Tablets (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Azithromycin 250mg Tablets (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Lansoprazole Capsules (Wockhardt) – Quality Control Issues (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Tamsulosin 0.4mg Capsules (Wockhardt) – Quality Concerns (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Lisinopril Tablets (Wockhardt) – Quality Control Issues (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Metoprolol Succinate Tablets (Wockhardt) – CGMP Deviation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

Captopril Tablets (Wockhardt) – CGMP Deviation (2015)

CGMP Deviations: Firm did not adequately investigate customer complaints.

Class IIModerate

FDAApr 22, 2015Nationwide• Wockhardt Usa Inc.

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