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Recall Observatory FDA recall evidence

Drug product

PredniSONE Tablets USP, 1 mg, 100-count bottles, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC 0054-4741-25.

D-0008-2017

October 03, 2016

Class II

Product summary

Firm
West-Ward Pharmaceutical
Event
Event 75260
Status
Terminated
Classification
Class II
Quantity
15,109 bottles
Official record key
drug-enforcement:D-0008-2017

Official wording

Reason: Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.

Code information: Lot # 660621A, Exp 01/31/18

Distribution pattern: US Nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed Tablet/Capsule Specifications: Discovery of an underweight tablet.