D-1253-2015 Class II Terminated
FDA drug recall D-1253-2015 was initiated by Wockhardt Usa Inc. on Apr 22, 2015 and is designated Class II. Reason for recall: CGMP Deviations: Firm did not adequately investigate customer complaints. The recall status is terminated (terminated May 9, 2018). Affected quantity: 407,958 Bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Jul 29, 2015
- Initiation Date
- Apr 22, 2015
- Termination Date
- May 9, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 407,958 Bottles
Product description
Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B) 500 Count Bottles (NDC: 64679-516-03), 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 #: LN10896, Expiry: 4/30/2015; Lot #: LN10901, Expiry: 4/30/2015; Lot #:LN10902, Expiry: 4/30/2015; Lot #: LN10903, Expiry: 4/30/2015; Lot #: LN11020, Expiry: 5/31/2015; Lot #: LN11021, Expiry: 5/31/2015; Lot #: LN11055, Expiry: 5/31/2015; Lot #: LN11056, Expiry: 5/31/2015; Lot #: LN11149, Expiry: 5/31/2015, Lot #: LN11150, Expiry: 5/31/2015; Lot #: LN11267, Expiry: 6/30/2015; Lot #: LN11357, Expiry: 7/31/2015; Lot #: LN11387, Expiry: 8/31/2015; Lot #: LN11421, Expiry: 9/30/2015. B) Lot #: LN10808, Expiry: 4/30/2015; Lot #: LN11083, Expiry: 5/31/2015; Lot #: LN11084, Expiry: 5/31/2015; Lot #: LN11085, Expiry: 5/31/2015; Lot #: LN11089, Expiry: 5/31/2015; Lot #: LN11109, Expiry: 5/31/2015; Lot #: LN11110, Expiry: 5/31/2015, Lot #: LN11120, Expiry: 5/31/2015; Lot #: LN11121, Expiry: 5/31/2015; Lot #: LN11186, Expiry: 5/31/2015; Lot #: LN11187, Expiry: 6/30/2015; Lot #: LN11188, Expiry: 6/30/2015; Lot #: LN11206, Expiry: 6/30/2015; Lot #: LN11226, Expiry: 6/30/2015; Lot #: LN11227, Expiry: 6/30/2015; Lot #: LN11233, Expiry: 6/30/2015; Lot #: LN11251, Expiry: 6/30/2015; Lot #: LN11257, Expiry: 6/30/2015; Lot #: LN11262, Expiry: 7/31/2015; Lot #: LN11263, Expiry:7/31/2015; Lot #: LN11274, Expiry: 7/31/2015; Lot#: LN11288, Expiry: 7/31/2015; Lot #: LN11370; Expiry: 8/31/2015; Lot #: LN11371, Expiry: 8/31/2015; Lot #: LN11378, Expiry: 8/31/2015; Lot #: LN11384, Expiry: 8/31/2015; Lot #: LN11400, Expiry: 9/30/2015; Lot #: LN11402, Expiry: 9/30/2015; Lot #: LN11406, Expiry: 9/30/2015; Lot #: LN11412, Expiry: 9/30/2015; Lot #: LN11416, Expiry: 9/30/2015; Lot #: LN11428, Expiry: 9/30/2015.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1253-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026