Reported Jul 29, 2015 · Terminated
Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets, Packaged in A) 100 Count Bottles (NDC:…
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?
- Metoprolol Succinate Extended-Release Tablets, USP, 100 mg Tablets
- Packaged in A) 100 Count Bottles (NDC64679-0736-02)
- B) 500 Count Bottles (NDC
64679-0736-03)and C) 12
- x 30 Tablet Dispenser Pack Cartons (NDC64679-0736-09), Rx Only
- Manufactured byWockhardt Limited, Mumbai, India
- Distributed by
Wockhardt USA LLC20 Waterview Blvd. ParsippanyNJ 07054 USA
- Lot codes and dates
22 of 22 products
Products covered by this recall # Product as published 1 LN11010, Expiry: 4/30/2015 2 Lot #: LN11011, Expiry: 4/30/2015 3 Lot #: LN11135, Expiry: 5/31/2015 4 Lot #: LN11136, Expiry: 5/31/2015 5 Lot #: LN11137, Expiry: 5/31/2015 6 Lot #: LN11138, Expiry: 5/31/2015 7 Lot #: LN11242, Expiry: 6/30/2015 8 Lot #: LN11243, Expiry: 6/30/2015. B) Lot #: LN11033, Expiry: 4/30/2015 9 Lot #: LN11034, Expiry: 4/30/2015 10 Lot #: LN11157, Expiry: 5/31/2015 11 Lot #: LN11158, Expiry: 5/31/2015 12 Lot #: LN11159, Expiry: 5/31/2015 13 Lot #: LN11160, Expiry: 5/31/2015 14 Lot #: LN11218, Expiry: 5/31/2015 15 Lot #: LN11219, Expiry: 5/31/2015 16 Lot #: LN11220, Expiry: 5/31/2015 17 Lot #: LN11222, Expiry: 6/30/2015 18 Lot #: LN11403, Expiry: 6/30/2015 19 Lot #: LN11413, Expiry: 8/31/2015 20 Lot #: LN11417, Expiry: 8/31/2015 - Amount recalled
- A) 77,967 Bottles, B) 26,785 Bottles, and C) 5,463 Cartons.
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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