Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Class I - DangerousWhat Should You Do?
- Check if you have this product: A) Lot #: LM10739, Expiry: 4/30/2015; Lot #: LM10991, Expiry: 5/31/2015; Lot #: LM11264, Expiry: 6/30/2015; Lot #: LM12019, Expiry: 11/30/2015; Lot #: LN10100, Expiry: 12/31/2015; Lot #: LN10220, Expiry: 12/31/2015; Lot #: LN10227, Expiry: 12/31/2015; Lot #: LN10228, Expiry: 12/31/2015; Lot #: LN11405, Expiry: 9/30/2016. B) Lot #: LM11015, Expiry: 5/31/2015; Lot #: LM11609, Expiry: 9/30/2015; Lot #: LM11883, Expiry: 10/31/2015; Lot #: LM11918, Expiry: 10/31/2015; Lot #: LN10274, Expiry: 12/31/2015; Lot #: LN11045, Expiry: 4/30/2016; Lot #: LN11327, Expiry: 12/31/2015; Lot #: LN11332, Expiry: 7/31/2016.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- 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:
Azithromycin Tablets, USP, 500 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0964-01) and B) 3 x 3 Tablet Card Cartons (NDC: 64679-964-05), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Product Codes/Lot Numbers:
A) Lot #: LM10739, Expiry: 4/30/2015; Lot #: LM10991, Expiry: 5/31/2015; Lot #: LM11264, Expiry: 6/30/2015; Lot #: LM12019, Expiry: 11/30/2015; Lot #: LN10100, Expiry: 12/31/2015; Lot #: LN10220, Expiry: 12/31/2015; Lot #: LN10227, Expiry: 12/31/2015; Lot #: LN10228, Expiry: 12/31/2015; Lot #: LN11405, Expiry: 9/30/2016. B) Lot #: LM11015, Expiry: 5/31/2015; Lot #: LM11609, Expiry: 9/30/2015; Lot #: LM11883, Expiry: 10/31/2015; Lot #: LM11918, Expiry: 10/31/2015; Lot #: LN10274, Expiry: 12/31/2015; Lot #: LN11045, Expiry: 4/30/2016; Lot #: LN11327, Expiry: 12/31/2015; Lot #: LN11332, Expiry: 7/31/2016.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1263-2015
Related Recalls
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.