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Clobetasol Ointment (Taro) – Bacterial Contamination (2021)

Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria

FDADec 15, 2021Nationwide• Taro Pharmaceuticals U.S.A., Inc.

Brinzolamide Suspension (Teva) – Defective Container (2021)

Defective Container: The notch in the cap that fits into the nozzle of the dropper could break off and block the dropper possibly resulting in the product not dispensing.

Class IIModerate

FDADec 8, 2021Nationwide• Teva Pharmaceuticals USA

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Clobetasol Ointment (Taro) – Bacterial Contamination (2021)

Brinzolamide Suspension (Teva) – Defective Container (2021)

Diclofenac Sodium Solution (Direct Rx) – Leaking Containers (2021)

Lidocaine/Epinephrine Injection (Edge Pharma) – Sterility Risk (2021)

Lidocaine HCl Buffered Injection (Edge Pharma) – sterility issue (2021)

BLT Topical Cream (Edge Pharma) – Manufacturing Deviation (2021)

Profound-PE Dental Gel (Edge Pharma) – Manufacturing Deviation (2021)

LET Topical Gel (Edge Pharma) – Manufacturing Deviation (2021)

Vancomycin Injection (Edge Pharma) – Sterility Risk (2021)

ALUM Concentrate (Edge Pharma) – sterility concerns (2021)

Promethazine HCl Ointment (Edge Pharma) – Manufacturing Deviation (2021)

Vitamin K Oral Solution (Edge Pharma) – Manufacturing Deviation (2021)

Physicians CARE Pain Reliever (Medique) – Manufacturing Violations (2021)

Lidocaine HCl/Oxymetazoline HCl Nasal Solution (Edge Pharma) – manufacturing deviation (2021)

LT Topical Cream (Edge Pharma) – manufacturing deviation (2021)

Phenylephrine HCl/Lidocaine Solution (Edge Pharma) – sterility issue (2021)

CSF-HC Otic Insufflation Capsule (Edge Pharma) – manufacturing deviation (2021)

Profound-PE Dental Gel (Edge Pharma) – manufacturing deviation (2021)

Profound Dental Gel (Edge Pharma) – manufacturing deviation (2021)

Epinephrine/Lidocaine HCl Ophthalmic Solution (Edge Pharma) – sterility issue (2021)