🔍 RecallPedia

Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01.

Class I - Dangerous
💊 Drugs Recalled: April 22, 2015 Wockhardt Usa Prescription Drugs Nationwide

What Should You Do?

  1. Check if you have this product:
    Lot #: DM11774, Expiry: 6/30/2015; Lot #: DM13056, Expiry: 10/31/2015; Lot #: DM13117, Expiry: 10/31/2015; Lot #: DM13159, Expiry: 10/31/2015; Lot #: DM13186, Expiry: 10/31/2015; Lot #: DM13187, Expiry: 10/31/2015; Lot #: DM13188, Expiry: 10/31/2015; Lot #: DN10003, Expiry: 11/30/2015; Lot #: DN10045, Expiry: 11/30/2015; Lot #: DN10046, Expiry: 11/30/2015; Lot #: DN10389, Expiry: 1/31/2016; Lot #: DN10412, Expiry: 1/31/2016; Lot #: DN10604, Expiry: 1/31/2016.
  2. Do not eat it: Even if it looks and smells fine, do not consume this product.
  3. Throw it away or return it: You can return the product to the store for a full refund.
  4. Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
  5. Report problems: Report any issues to the FDA's Safety Reporting Portal.

⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.

Recall Details

Company:
Wockhardt Usa Inc.
Reason for Recall:
CGMP Deviations: Firm did not adequately investigate customer complaints.
Classification:
Class I - Dangerous

Dangerous or defective products that predictably could cause serious health problems or death.

Status:
terminated

Product Information

Full Description:

Amlodipine Besylate Tablets, 2.5 mg Tablets, Packaged in 90 Count Bottles, Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA. NDC: 64679-421-01.

Product Codes/Lot Numbers:

Lot #: DM11774, Expiry: 6/30/2015; Lot #: DM13056, Expiry: 10/31/2015; Lot #: DM13117, Expiry: 10/31/2015; Lot #: DM13159, Expiry: 10/31/2015; Lot #: DM13186, Expiry: 10/31/2015; Lot #: DM13187, Expiry: 10/31/2015; Lot #: DM13188, Expiry: 10/31/2015; Lot #: DN10003, Expiry: 11/30/2015; Lot #: DN10045, Expiry: 11/30/2015; Lot #: DN10046, Expiry: 11/30/2015; Lot #: DN10389, Expiry: 1/31/2016; Lot #: DN10412, Expiry: 1/31/2016; Lot #: DN10604, Expiry: 1/31/2016.

Official Source

Always verify recall information with the official FDA source:

View on FDA.gov

FDA Recall Number: D-1243-2015

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