Famotodine Tablets, USP, 20 mg Tablets, Packaged in A) 30 Count Bottles (NDC: 64679-936-01), B) 100 Count Bottles(NDC: 64679-936-02), and C) 1000 Count Bottles (NDC: 64679-936-03), Rx only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.

Reason: CGMP Deviations: Firm did not adequately investigate customer complaints.

Code information: A) Lot #: LM10708, Expiry: 4/30/2015; Lot #: LM10859, Expiry: 5/31/2015; Lot #: LM11200, Expiry: 7/31/2015; Lot #: LM11679, Expiry: 9/30/2015; Lot #: LN10465, Expiry: 1/31/2016; Lot #: LN10750, Expiry: 3/31/2016; Lot #: LN11385, Expiry: 9/30/2016. B) Lot #: LM10709, Expiry: 4/30/2015; Lot #: LM10719, Expiry: 4/30/2015; Lot #: LM10721, Expiry: 4/30/2015; Lot #: LM10827, Expiry: 5/31/2015; Lot #: LM10828, Expiry: 5/31/2015; Lot #: LM10912, Expiry: 5/31/2015, Lot #: LM11205, Expiry: 7/31/2015; Lot #: LM11206, Expiry: 7/31/2015, Lot #: LM11239. Expiry: 7/31/2015; Lot #: LM11680, Expiry: 9/30/2015; Lot #: LM11822, Expiry: 10/31/2015; Lot #: LM11993, Expiry: 10/31/2015; Lot #: LN10114, Expiry: 12/31/2015; Lot #: LN10115, Expiry: 12/31/2015; Lot #: LN10695, Expiry: 3/31/2016; Lot #: LN10696, Expiry: 3/31/2016; Lot #: LN10697, Expiry: 3/31/2016; Lot #: LN10745, Expiry: 3/31/2016; Lot #: LN10749, Expiry: 3/31/2016; Lot #: LN11249, Expiry: 6/30/2016; Lot #: LN11374, Expiry: 8/31/2016; Lot #: LN11376, Expiry: 8/31/2016; Lot #: LN11382, Expiry: 7/31/2016; Lot #: LN11386, Expiry: 9/30/2016. C) Lot #: LM10685, Expiry: 4/30/2015; Lot #: LM10687, Expiry: 4/30/2015; Lot #: LM10691, Expiry: 4/30/2015; Lot #: LM10692, Expiry: 4/30/2015; Lot #: LM10707, Expiry: 4/30/2015; Lot #: LM10735, Expiry: 4/30/2015; Lot #: LM10741, Expiry: 4/30/2015; Lot #: LM10743, Expiry: 4/30/2015; Lot #: LM10860, Expiry: 5/31/2015; Lot #: LM10861, Expiry: 5/31/2015; Lot #: LM10862, Expiry: 5/31/2015; Lot #: LM10869, Expiry: 5/31/2015; Lot #: LM10911, Expiry: 5/31/2015; Lot #: LM11158, Expiry: 4/30/2015; Lot #: LM12039, Expiry: 10/31/2015; Lot #: LN10426, Expiry: 1/31/2016; Lot #: LN10427, Expiry: 1/31/2016; Lot #: LN10428, Expiry: 1/31/2016; Lot #: LN10435, Expiry: 1/31/2016; Lot #: LN10463, Expiry: 1/31/2016; Lot #: LN10464, Expiry: 1/31/2016; Lot #: LN10674, Expiry: 3/31/2016; Lot #: LN10675, Expiry: 3/31/2016; Lot #: LN10676, Expiry: 3/31/2016; Lot #: LN10751, Expiry: 3/31/2016; Lot #: LN11017, Expiry: 5/31/2016; Lot #: LN11018, Expiry: 5/31/2016; Lot #: LN11023, Expiry: 5/31/2016; Lot #: LN11216, Expiry: 6/30/2016; Lot #: LN11217, Expiry: 6/30/2016; Lot #: LN11391, Expiry: 9/30/2016; Lot #: LN11394, Expiry: 9/30/2016; Lot #: LN11401, Expiry: 9/30/2016; Lot #: LN11408, Expiry: 9/30/2016; Lot #: LN11410, Expiry: 9/30/2016.

Distribution pattern: U.S. Nationwide including Puerto Rico.