PROCHLORPERAZINE EDISYLATE INJECTION recalled over sterility concerns
- Recall date
- May 21, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Heritage Pharmaceuticals, Inc. recalls PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., H…
- Recall number
- D-1397-2019
- FDA classification
- Class I
- Brand / firm
- Heritage Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide in the USA
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) .
Class I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.
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
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