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Benzhydrocodone Tablets (KVK-Tech) – Impurity Issue (2020)

Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A

Class IIILow

FDADec 18, 2020Nationwide• KVK-Tech, Inc.

Fentanyl Bupivacaine (SCA Pharmaceuticals) – sterility concern (2020)

Lack of Assurance of Sterility; potential for a defective syringe cap, resulting in a non-integral unit

Class IIModerate

FDADec 17, 2020Nationwide• SCA Pharmaceuticals

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Benzhydrocodone Tablets (KVK-Tech) – Impurity Issue (2020)

Fentanyl Bupivacaine (SCA Pharmaceuticals) – sterility concern (2020)

Esmolol HCl Injection (SCA) – Sterility Risk (2020)

Ephedrine Sulfate Injection (SCA) – Sterility Risk (2020)

Labetalol HCl Injection (SCA) – Sterility Risk (2020)

Hydromorphone HCl Injection (SCA) – Sterility Risk (2020)

Ephedrine Injection (SCA) – Sterility Risk (2020)

Cephalexin Suspension (Ascend) – Impurity Failure (2020)

Fentanyl/Ropivacaine Injection (SCA) – Sterility Risk (2020)

Sodium Citrate 4% Anticoagulation Solution (SCA Pharmaceuticals) – Sterility Concern (2020)

Morphine Sulfate Sodium Chloride Injection (SCA Pharmaceuticals) – Sterility Concern (2020)

Glycopyrrolate Injection (SCA Pharmaceuticals) – Sterility Concern (2020)

Fentanyl Injection (SCA Pharmaceuticals) – Sterility Concern (2020)

Atropine Sulfate Injection (SCA Pharmaceuticals) – Sterility Concern (2020)

Ketorolac Tromethamine Injection (Fresenius Kabi) – Particulate Matter (2020)

Lidocaine HCl 1% Injection (SCA Pharmaceuticals) – Sterility Concern (2020)

Rocuronium Bromide Injection (SCA Pharmaceuticals) – Sterility Concern (2020)

Neostigmine Methylsulfate Injection (SCA Pharmaceuticals) – Sterility Concern (2020)

Lidocaine HCl 2% Injection (SCA Pharmaceuticals) – Sterility Concern (2020)

Ketamine Sodium Chloride Injection (SCA Pharmaceuticals) – Sterility Concern (2020)