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Recall Observatory FDA recall evidence

Drug product

Back Pain-Off (caffeine 50mg, magnesium salicylate 290mg) Tablets 2-count packets, Mfd for MEDIQUE PRODUCTS, Fort Myers, FL 33967, NDC 47682-073-00

D-0476-2022

January 24, 2022

Class II

Product summary

Firm
Ultra Seal Corporation
Event
Event 89464
Status
Terminated
Classification
Class II
Quantity
1,959,267 packets
Official record key
drug-enforcement:D-0476-2022

Official wording

Reason: cGMP deviations

Code information: Lot #: 9708, Exp. Date 07/2022; AK9810, Exp. Date 09/2022; AK9946, K9946, Exp. Date 12/2022

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations