FDA-Drug2019-06-19Class I
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
Heritage Pharmaceuticals, Inc.
Hazard
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) .
Sold states
Nationwide in the USA
Affected count
55,480 2 mL vials
Manufactured in
1 Tower Center Blvd Ste 1700, N/A, East Brunswick, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1397-2019Don't want to check this manually?
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