Drug recall D-1397-2019
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
Reason for recall
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) .
Lots and codes
Lot: VPCA172, EXP April 2020
Recall details
- Recalling firm
- Heritage Pharmaceuticals, Inc., East Brunswick, NJ
- Quantity
- 55,480 2 mL vials
- Distribution
- Nationwide in the USA
- Type
- Voluntary: Firm initiated
- Recall initiated
- May 21, 2019
- Terminated
- January 11, 2022
Related products
- Prochlorperazine Edisylate – drug information
- NDC 23155-294 Prochlorperazine Edisylate · Prochlorperazine Edisylate 5 mg/mL · Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.