Tamsulosin Hydrochloride Capsules recall: CGMP Deviations
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.
Why was Tamsulosin Hydrochloride Capsules recalled?
CGMP Deviations: Firm did not adequately investigate customer complaints.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- 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.
- Recalling firm
- Wockhardt Usa Inc.
- Quantity
- 407,958 Bottles
- Distribution
- U.S. Nationwide including Puerto Rico.
- Recall date
- July 29, 2015
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)