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Recall Observatory FDA recall evidence

Drug product

Metoprolol Tartrate Tablets USP 50 mg, 1000 count bottle, Rx only, Manufactured in india By: Emcure Pharmaceuticals LTD. Hinjwadi, Pune, India, Manufactured for TEVA Phamaceuticals USA, Sellersville, PA 18960, NDC 0093-0733-10

D-1409-2012

May 16, 2012

Class II

Product summary

Firm
Teva Pharmaceuticals USA, Inc.
Event
Event 61871
Status
Terminated
Classification
Class II
Quantity
2,268 bottles
Official record key
drug-enforcement:D-1409-2012

Official wording

Reason: Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)

Code information: Lot #TE1Y261, Exp, 12/2013

Distribution pattern: Ohio

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Tablet Thickness: Potential for some tablets not conforming to weight specifications (under and over weight)