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Class II · ModerateRecall completed

Metoprolol Succinate Extended-Release Tablets

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberA) Lot #: LN10967, Expiry: 4/30/2015; Lot #: LN10968, Expiry: 4/30/2015; Lot #: LN10969, Expiry: 4/30/2015; Lot #: LN11076, Expiry: 4/30/2015; Lot #: LN11077, Expiry: 4/30/2015; Lot #: LN11078, Expiry: 4/30/2015; Lot #: LN11126, Expiry: 5/31/2015; Lot #: LN11127, Expiry: 5/31/2015; Lot #: LN11326, Expiry: 6/30/2015; Lot #: LN11330, Expiry: 6/30/2015; Lot #: LN11331, Expiry: 6/30/2015; Lot #: LN11335, Expiry: 7/31/2015. B) Lot #: LN11093, Expiry: 4/30/2015; Lot #: LN11094, Expiry: 4/30/2015; Lot #: LN11095, Expiry: 4/30/2015; Lot #: LN11096, Expiry: 4/30/2015; Lot #: LN11097, Expiry: 4/30/2015; Lot #: LN11101, Expiry: 5/31/2015; Lot #: LN11102, Expiry: 5/31/2015; Lot #: LN11103, Expiry: 5/31/2015; Lot #: LN11107, Expiry: 5/31/2015; Lot #: LN11108, Expiry: 5/31/2015; Lot #: LN11131, Expiry: 5/31/2015; Lot #: LN11132, Expiry: 5/31/2015; Lot #: LN11133, Expiry: 5/31/2015; Lot #: LN11203, Expiry: 5/31/2015; Lot #: LN11204, Expiry: 5/31/2015; Lot #: LN11325, Expiry: 6/30/2015. C) Lot #: LN10988, Expiry: 4/30/2015. D) Lot #: LN11192, Expiry: 5/31/2015; Lot #: LN11197, Expiry: 5/31/2015; Lot #:LN11198, Expiry: 5/31/2015.
Where it was soldU.S. Nationwide including Puerto Rico.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

CGMP Deviations: Firm did not adequately investigate customer complaints.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byWockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA foreign manufacturer
Distributed by / forWockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA
NDC64679-0735-02
Show the full FDA record
Full product labelMetoprolol Succinate Extended-Release Tablets, USP, 50 mg Tablets, Packaged in A) 100 Count Bottles (NDC: 64679-0735-02), B) 500 Count Bottles (NDC: 64679-0735-03), C) 4000 Count Pouches, For Repacking Only (NDC: 64679-0735-08), and D) 12 x 30 Tablet Dispenser Pack Cartons (NDC: 64679-0735-09), Rx Only. Manufactured by: Wockhardt Limited, Mumbai, India. Distributed by: Wockhardt USA LLC 20 Waterview Blvd. Parsippany, NJ 07054 USA.
Recalling firmWockhardt Usa Inc.
DistributionU.S. Nationwide including Puerto Rico.
QuantityA) 136,839 Bottles, B) 37,184 Bottles, C) 309 Pouches, and D) 9,764 Cartons.
Recall initiated2015-04-22
Report date2015-07-29
Recall completed2018-05-09
Recall numberD-1271-2015
ClassificationClass II
FDA statusTerminated
Origin on fileParsippany NJ United States

Related

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.