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Recall Observatory FDA recall evidence

Drug product

Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01

D-0099-2019

August 06, 2018

Class II

Product summary

Firm
Teva Pharmaceuticals USA
Event
Event 80790
Status
Terminated
Classification
Class II
Quantity
3,397 bottles
Official record key
drug-enforcement:D-0099-2019

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 #: 1210888A, Exp 03/2019

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.