FDA Recall D-1397-2019
Heritage Pharmaceuticals, Inc. · East Brunswick, NJ
Class I — life-threatening Terminated 966 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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) .
Recall record
- Recall number
D-1397-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide in the USA
- Recall initiated
- 2019-05-21
- Classified by FDA Center
- 2019-06-19
- FDA published
- 2019-06-19
- Terminated
- 2022-01-11
- Recalling firm
- Heritage Pharmaceuticals, Inc.
- Firm location
- East Brunswick, NJ
Drug identification
- Brand name(s)
- PROCHLORPERAZINE EDISYLATE
- Generic name(s)
- PROCHLORPERAZINE EDISYLATE
- Manufacturer(s)
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- NDC(s)
23155-294- Route(s)
- INTRAMUSCULAR, INTRAVENOUS