Recalls / Class II

Class IID-1248-2015

Product

Azithromycin Tablets, USP, 250 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-0961-01), B) 3,500 Count Pouches (NDC: 64679-961-08), and C) 3 x 6 Tablet Card Cartons (NDC: 64679-961-05), 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 #: LM10712, Expiry: 4/30/2015; Lot #: LM10874, Expiry: 4/30/2015; Lot #: LM11040, Expiry: 5/31/2015; Lot #: LM11169, Expiry: 6/30/2015; Lot #: LM11401, Expiry: 6/30/2015; Lot #: LM12132, Expiry: 11/30/2015; Lot #: LN10039, Expiry: 12/31/2015; Lot #: LN10263, Expiry: 12/31/2015; Lot #: LN10276, Expiry: 12/31/2015; Lot #: LN10417, Expiry: 1/31/2016, Lot #: LN11365, Expiry: 8/31/2016. B) Lot #: LN11264, Expiry: 7/31/2015; Lot #: LN11373, Expiry: 8/31/2015; Lot #: LN11375, Expiry: 8/31/2015. C) Lot #: LM10686, Expiry: 4/30/2015; Lot #: LM10757, Expiry: 4/30/2015; Lot #: LM10855, Expiry: 4/30/2015; Lot #: LM10893, Expiry: 5/31/2015; Lot #: LM10945, Expiry: 5/31/2015; Lot #: LM10989, Expiry: 4/30/2015; Lot #: LM11117, Expiry: 6/30/2015; Lot #: LM11168, Expiry: 6/30/2015; Lot #: LM11214, Expiry: 6/30/2015; Lot #: LM11624, Expiry: 9/30/2015; Lot #: LM11797, Expiry: 10/31/2015; Lot #: LM11820, Expiry: 10/31/2015; Lot #: LM11959, Expiry: 10/31/2015; Lot #: LM12000, Expiry: 10/31/2015; Lot #: LM12027, Expiry: 11/30/2015; Lot #: LM12128, Expiry: 11/30/2015; Lot #: LN10014, Expiry: 11/30/2015; Lot #: LN10055, Expiry: 11/30/2015; Lot #: LN10089, Expiry: 11/30/2015; Lot #: LN10122, Expiry: 11/30/2015; Lot #: LN10156, Expiry: 12/31/2015; Lot #: LN10196, Expiry: 12/31/2015; Lot #: LN10225, Expiry: 12/31/2015; Lot #: LN10307, Expiry: 1/31/2016; Lot #: LN10338, Expiry: 1/31/2016; Lot #: LN10382, Expiry: 1/31/2016; Lot #: LN10416, Expiry: 1/31/2016; Lot #: LN10431, Expiry: 1/31/2016; Lot #: LN10461, Expiry: 1/31/2016; Lot #: LN10618, Expiry: 2/29/2016; Lot #: LN11144, Expiry: 5/31/2016; Lot #: LN11183, Expiry: 6/30/2016; Lot #: LN11236, Expiry: 6/30/2016; Lot #: LN11276, Expiry: 7/31/2016; Lot #: LN11347, Expiry: 7/31/2016; Lot #: LN11360, Expiry: 7/31/2016, Lot #: LN11366, Expiry: 8/31/2016; Lot #: LN11372, Expiry: 8/31/2016; Lot #: LN11395, Expiry: 9/30/2016; Lot #: LN11404, Expiry: 9/30/2016; Lot #: LN11419, Expiry: 9/30/2016.

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) 280,520 Bottles, B) 571 Pouches, and C) 1,629,253 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-1248-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.