Recalls / Class II

Class IID-1250-2015

Product

Famotodine Tablets, USP, 40 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-937-01), B) 100 Count Bottles (NDC: 64679-937-02), and C) 1000 Count Bottles (NDC: 64679-937-03), 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 #: LM10806, Expiry: 5/31/2015; Lot #: LM11099, Expiry: 6/30/2015; Lot #: LM11297, Expiry: 7/31/2015; Lot #: LM11933, Expiry: 10/31/2015; Lot #: LN10180, Expiry: 12/31/2015; Lot #: LN10547, Expiry: 2/29/2016. B) Lot #: LM10784, Expiry: 5/31/2015; Lot #: LM10791, Expiry: 5/31/2015; Lot #: LM10812, Expiry: 5/31/2015; Lot #: LM11112, Expiry: 6/30/2015; Lot #: LM11298, Expiry: 7/31/2015; Lot #: LM11299, Expiry: 7/31/2015; Lot #: LM11625, Expiry: 8/31/2015; Lot #: LN10182, Expiry: 12/31/2015; Lot #: LN10548, Expiry: 2/29/2016; Lot #: LN11115, Expiry: 5/31/2016; Lot #: LN11367, Expiry: 8/31/2016; Lot #: LN11369, Expiry: 8/31/2016. C) Lot #: LM10813, Expiry: 5/31/2015; Lot #: LM11085, Expiry: 6/30/2015; Lot #: LM11088, Expiry: 6/30/2015; Lot #: LM11296, Expiry: 7/31/2015; Lot #: LM11932, Expiry: 10/31/2015; Lot #: LN10181, Expiry: 12/31/2015; Lot #: LN10549, Expiry: 2/29/2016; Lot #: LN11114, Expiry: 5/31/2016; Lot #: LN11359, Expiry: 8/31/2016.

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) 70,428 Bottles, B) 128,420 Bottles, and C) 8,101 Bottles.

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-1250-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.