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Recall Observatory FDA recall evidence

Drug product

Alprazolam 1 mg Tablets, USP, 500 count Bottle, Rx Only , C IV, Manufactured by: Actavis Elizabeth LLC 200 Elmora Avenue Elizabeth, NJ 07207 USA, NDC 0228-2031-50

D-1153-2014

February 10, 2014

Class II

Product summary

Firm
Actavis Elizabeth LLC
Event
Event 67519
Status
Terminated
Classification
Class II
Quantity
9447 Bottles
Official record key
drug-enforcement:D-1153-2014

Official wording

Reason: Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.

Code information: Lot # 1826E131, Exp 04/2015

Distribution pattern: Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Tablet/Capsule Specifications: Complaints were received for significant tablet erosion for Alprazolam 1 mg.

Field note

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