Recalls / Class III
Class IIID-0592-2024
Product
Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2.5 mg/mL), packaged as (a) 25x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-7; (b) 5x2 mL Single-Dose Vial per carton, Vial NDC: 70710-1643-1; Carton NDC 70710-1643-5; Rx Only, Manufactured by: Zydus Lifesciences Ltd. Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA)Inc., Pennington, NJ 08534,
- Brand name
- Verapamil Hydrochloride
- Generic name
- Verapamil Hydrochloride
- Active ingredient
- Verapamil Hydrochloride
- Route
- Intravenous
- NDCs
- 70710-1643, 70710-1644
- FDA application
- ANDA214215
- Affected lot / code info
- Lot# (a) Lots L300255, L300262, Exp Date 07/31/2025; (b)L300263, Exp Date 08/31/2025
Why it was recalled
Cross contamination with other products.
Recalling firm
- Firm
- Zydus Pharmaceuticals (USA) Inc
- Manufacturer
- Zydus Pharmaceuticals USA Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 73 Route 31 N, N/A, Pennington, New Jersey 08534-3601
Distribution
- Quantity
- 170,755 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2024-07-02
- FDA classified
- 2024-07-10
- Posted by FDA
- 2024-07-17
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0592-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.