Recalls / Class I
Class ID-1397-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- Prochlorperazine Edisylate
- Generic name
- Prochlorperazine Edisylate
- Active ingredient
- Prochlorperazine Edisylate
- Route
- Intramuscular, Intravenous
- NDC
- 23155-294
- FDA application
- ANDA204147
- Affected lot / code info
- Lot: VPCA172, EXP April 2020
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) .
Recalling firm
- Firm
- Heritage Pharmaceuticals, Inc.
- Manufacturer
- Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1 Tower Center Blvd Ste 1700, N/A, East Brunswick, New Jersey 08816-1145
Distribution
- Quantity
- 55,480 2 mL vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2019-05-21
- FDA classified
- 2019-06-19
- Posted by FDA
- 2019-06-19
- Terminated
- 2022-01-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1397-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.