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Recall Observatory FDA recall evidence

Drug product

Phenobarbital Tablets USP, 30 mg, 1000 count bottles, Rx Only, Manufactured by West-ward Pharmaceutical Corp. Eatontown, NJ 07724, Distributed by Truxton, Inc., Bellmawr, NJ 08031, NDC 0463-6145-10

D-1112-2017

April 20, 2017

Class I

Product summary

Firm
C. O. Truxton
Event
Event 77082
Status
Terminated
Classification
Class I
Quantity
unknown
Official record key
drug-enforcement:D-1112-2017

Official wording

Reason: Labeling: Label Mixup; potentially mislabeled

Code information: Lot # 70926A; Exp. 11/17 Lot # 70981A; Exp. 01/18 Lot # H15A59; Exp. 08/18

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    mislabeled