Reported Jul 29, 2015 · Terminated
Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules, Packaged in A) 100 Count Bottles (NDC: 64679-516-02) and B)…
Wockhardt USA Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Wockhardt Usa Inc. · 20 Waterview Blvd Ste 3 · Parsippany, NJ · 07054-1271
Is this the product you have?
- Tamsulosin Hydrochloride Capsules, USP*, 0.4 mg Capsules
- Packaged in A) 100 Count Bottles (NDC64679-516-02)
- and B) 500 Count Bottles (NDC64679-516-03), Rx Only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed byWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
- Lot codes and dates
44 of 44 products
Products covered by this recall # Product as published 1 LN10896, Expiry: 4/30/2015 2 Lot #: LN10901, Expiry: 4/30/2015 3 Lot #:LN10902, Expiry: 4/30/2015 4 Lot #: LN10903, Expiry: 4/30/2015 5 Lot #: LN11020, Expiry: 5/31/2015 6 Lot #: LN11021, Expiry: 5/31/2015 7 Lot #: LN11055, Expiry: 5/31/2015 8 Lot #: LN11056, Expiry: 5/31/2015 9 Lot #: LN11149, Expiry: 5/31/2015, Lot #: LN11150, Expiry: 5/31/2015 10 Lot #: LN11267, Expiry: 6/30/2015 11 Lot #: LN11357, Expiry: 7/31/2015 12 Lot #: LN11387, Expiry: 8/31/2015 13 Lot #: LN11421, Expiry: 9/30/2015. B) Lot #: LN10808, Expiry: 4/30/2015 14 Lot #: LN11083, Expiry: 5/31/2015 15 Lot #: LN11084, Expiry: 5/31/2015 16 Lot #: LN11085, Expiry: 5/31/2015 17 Lot #: LN11089, Expiry: 5/31/2015 18 Lot #: LN11109, Expiry: 5/31/2015 19 Lot #: LN11110, Expiry: 5/31/2015, Lot #: LN11120, Expiry: 5/31/2015 20 Lot #: LN11121, Expiry: 5/31/2015 - Amount recalled
- 407,958 Bottles
This recall covers 35 products
The agency filed one notice per product. You are reading one of them; the other 34 are below.
22 more are in the archive.
Where it was sold
- Nationwide
- PR
Why it was recalled
CGMP Deviations: Firm did not adequately investigate customer complaints.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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