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Recall Observatory FDA recall evidence

Drug product

Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 --- NDC 55289-765-30

D-1057-2017

July 28, 2017

Class II

Product summary

Firm
PD-Rx Pharmaceuticals, Inc.
Event
Event 77847
Status
Terminated
Classification
Class II
Quantity
100 bottles
Official record key
drug-enforcement:D-1057-2017

Official wording

Reason: Failed Tablet/Capsule Specification: out of specification for tablet weight.

Code information: Lot: A17F55 Exp. 06/30/2018

Distribution pattern: Nationwide

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out of specification