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Recall Observatory FDA recall evidence

Drug product

Clonidine Hydrochloride Tablets, USP, 0.1 mg, 100-count bottles, Rx only, Packaged by PD-RX Pharmaceuticals, Inc., Oklahoma City, OK 73127, MFG: Mutual Pharm. Co. Inc., Philadelphia, PA 19124, NDC 43063-509-01

D-0559-2016

July 10, 2015

Class II

Product summary

Firm
PD-Rx Pharmaceuticals, Inc.
Event
Event 72942
Status
Terminated
Classification
Class II
Quantity
9 bottles
Official record key
drug-enforcement:D-0559-2016

Official wording

Reason: cGMP Deviations

Code information: Lot# B14D26, Exp 02/16

Distribution pattern: Alabama

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP Deviations