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Cyclobenzaprine Hydrochloride (Teva) – Microbial Count Issue (2021)

CGMP Deviations: Out of specification (OOS) test result for Total Aerobic Microbial Count (TAMC) and Total Yeast and Mold Count (TYMC) for an excipient batch of Dibasic Calcium Phosphate.

Class IIModerate

FDAJul 29, 2021Nationwide• Teva Pharmaceuticals USA

Erythromycin Topical Solution (Teligent) – Container Defect (2021)

Defective container: possibility for lack of seal integrity.

Class IIModerate

FDAJul 29, 2021Nationwide• Teligent Pharma, Inc.

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Cyclobenzaprine Hydrochloride (Teva) – Microbial Count Issue (2021)

Erythromycin Topical Solution (Teligent) – Container Defect (2021)

Nystatin Oral Suspension (PAI) – Potential Senna Carryover (2021)

Adenosine Injection (Teva) – Sterility Concern (2021)

Alprostadil Injection (Teva) – Sterility Concern (2021)

Metoclopramide Injection (Teva) – Sterility Concern (2021)

Vecuronium Bromide Injection (Teva) – Sterility Concern (2021)

Adenosine Injection (Teva) – Sterility Concern (2021)

Fexofenadine Hydrochloride Tablets (MAJOR) – Impurity Concerns (2021)

Cholestene Capsules (HPF) – Unapproved Marketing (2021)

Miss Slim Capsules (HIS Enterprise) – Unapproved Marketing (2021)

Tizanidine HCl Tablets 4mg (Dr. Reddy's) – Tablet Specification Failure (2021)

Econazole Nitrate Cream 1% (Teligent Pharma) – Product Mispack (2021)

Triamcinolone Acetonide Ointment 0.1% (Teligent Pharma) – Product Mispack (2021)

Digestive Enzyme Formula (New Dawn Nutrition) – Undeclared ingredients (2021)

Kroger Vitamin D3 Softgels – Unexpected Ingredient (2021)

AOD-9604 Injection (Innoveix) – Sterility Concern (2021)

Semorelin/Ipamorelin Injection (Innoveix) – Sterility Concern (2021)

Acetaminophen Extra Strength Tablets (LNK) – Incorrect Labeling (2021)

Sulfamethoxazole Trimethoprim Tablets (Aurobindo) – Metal Contamination (2021)