Recalls / Class II

Class IID-1263-2015

Product

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.

Affected lot / code info

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.

Why it was recalled

CGMP Deviations: Firm did not adequately investigate customer complaints.

Recalling firm

Firm

Wockhardt Usa Inc.

Notification channel

Letter

Type

Voluntary: Firm initiated

Address

20 Waterview Blvd Ste 3, N/A, Parsippany, New Jersey 07054-1271

Distribution

Quantity

A) 112,120 Bottles and B) 178,580 Cartons.

Distribution pattern

U.S. Nationwide including Puerto Rico.

Timeline

Recall initiated

2015-04-22

FDA classified

2015-07-17

Posted by FDA

2015-07-29

Terminated

2018-05-09

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1263-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.