D-1263-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 29, 2015
- Initiation Date
- April 22, 2015
- Termination Date
- May 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- A) 112,120 Bottles and B) 178,580 Cartons.
Product 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.
Reason for Recall
CGMP Deviations: Firm did not adequately investigate customer complaints.
Distribution Pattern
U.S. Nationwide including Puerto Rico.
Code Information
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.