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Recall Observatory FDA recall evidence

Drug product

Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60

D-0098-2019

August 06, 2018

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 80790
Status
Terminated
Classification
Class II
Quantity
13,225 bottles
Official record key
drug-enforcement:D-0098-2019

Official wording

Reason: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

Code information: Lot #: 1237868A, 1248900A, Exp 5/2020

Distribution pattern: Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.