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Showing 3941–3960 of 14370 results

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Cephalexin Oral Suspension (Ascend Laboratories) – impurity specs (2020)

Failed Impurity/Degradation Specifications

Class IIModerate

FDADec 17, 2020Nationwide• Ascend Laboratories LLC

Phenylephrine HCl Injection (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

Phenylephrine HCl Injection (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

Hydromorphone HCl Injection (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

Lidocaine HCl Injection (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

Rocuronium Bromide (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

Phenylephrine HCl Injection (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

Ketamine Injection (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

Hydromorphone Sodium Chloride Injection (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

Succinylcholine Chloride Injection (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

Esomeprazole Magnesium Suspension 20mg (CIPLA) – Cross-Contamination (2020)

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

Class IIModerate

FDADec 17, 2020Nationwide• CIPLA

Morphine Sulfate Injection (SCA Pharmaceuticals) – sterility concern (2020)

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

FDADec 17, 2020Nationwide• SCA Pharmaceuticals

Succinylcholine Chloride (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

Esomeprazole Magnesium Suspension 40mg (CIPLA) – Cross-Contamination (2020)

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

Class IIModerate

FDADec 17, 2020Nationwide• CIPLA

Esomeprazole Magnesium Suspension (CIPLA) – contamination risk (2020)

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

Class IIModerate

FDADec 17, 2020Nationwide• CIPLA

Fentanyl High Dose Injection (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

Phenylephrine HCl Injection (SCA) – Sterility Risk (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

Ephedrine Sulfate Sodium Chloride Injection (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

Morphine Sulfate Sodium Chloride Injection (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

Succinylcholine Chloride (US Compounding) – labeling error (2020)

Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.

FDADec 16, 2020Nationwide• US Compounding Inc

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