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.
Class I - DangerousWhat Should You Do?
- Check if you have this product: 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.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- Wockhardt Usa Inc.
- Reason for Recall:
- CGMP Deviations: Firm did not adequately investigate customer complaints.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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.
Product Codes/Lot Numbers:
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.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-1253-2015
Related Recalls
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.
CGMP Deviations: An FDA inspection identified inadequate investigations of past market complaints.