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Class III: unlikely to cause harmOngoing

Zydus Pharmaceuticals (USA) Verapamil Hydrochloride Injection Recall

Verapamil Hydrochloride Injection, USP 5 mg / 2mL(2

Zydus Pharmaceuticals (USA) Inc · Pennington, NJ

Risk level
Class III
Reported by FDA
Jul 17, 2024
Recall ID
D-0592-2024
Check your lot numberHow we source this data

Summary

Zydus Pharmaceuticals (USA) recalled Verapamil Hydrochloride Injection starting Jul 2, 2024. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0592-2024 on Jul 17, 2024. Reason: Cross contamination with other products. Status: Ongoing.

Why it was recalled

Cross contamination with other products.

Product description

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,

Lot numbers, UPCs & expiration codes

Lot# (a) Lots L300255, L300262, Exp Date 07/31/2025; (b)L300263, Exp Date 08/31/2025

Where it was sold

Nationwide in the USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0592-2024
Classification
Class III
Status
Ongoing
Recall initiated
Jul 2, 2024
FDA report date
Jul 17, 2024
Quantity
170,755 vials
Recall type
Voluntary: Firm initiated
Recalling firm
Zydus Pharmaceuticals (USA) Inc

Original FDA data

Every field from FDA enforcement report D-0592-2024, exactly as published.

Show all FDA fields
City
Pennington
State
NJ
Status
Ongoing
Country
United States
Event ID
94912
Address
73 Route 31 N
Code information
Lot# (a) Lots L300255, L300262, Exp Date 07/31/2025; (b)L300263, Exp Date 08/31/2025
Postal code
08534-3601
Report date
Jul 17, 2024
Product type
Drugs
Recall number
D-0592-2024
Classification
Class III
Recalling firm
Zydus Pharmaceuticals (USA) Inc
Product quantity
170,755 vials
Reason for recall
Cross contamination with other products.
Voluntary / mandated
Voluntary: Firm initiated
Product description
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,
Distribution pattern
Nationwide in the USA
Recall initiation date
Jul 2, 2024
Initial firm notification
Letter
Center classification date
Jul 10, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0592-2024, published Jul 17, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

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