Class II · Moderate risk Ongoing
Prochlorperazine Maleate Tablets
Reason CGMP Deviations
Prochlorperazine Edisylate Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
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) .
What was recalled
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
- Recalling firm
- Heritage Pharmaceuticals, Inc.
- NDC code
- 23155-294-31
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1397-2019
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Prochlorperazine recalls
See all
Class III · Low risk Terminated
Prochlorperazine Maleate Tablets
Reason Subpotent Drug: Out of specification for assay at the 18-month stability timepoint.
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