Drug product
PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg for: Heritage Pharmaceuticals Inc. NDC 23155-294-31
D-1397-2019
Product summary
- Event
- Event 82918
- Status
- Terminated
- Classification
- Class I
- Quantity
- 55,480 2 mL vials
- Official record key
drug-enforcement:D-1397-2019
Official wording
Reason: Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
Code information: Lot: VPCA172, EXP April 2020
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Microbial contamination
Microbial growth