Skip to content
Recall Observatory FDA recall evidence

Drug product

Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832

D-0482-2022

January 24, 2022

Class II

Product summary

Firm
Ultra Seal Corporation
Event
Event 89464
Status
Terminated
Classification
Class II
Quantity
5,107,565 packets
Official record key
drug-enforcement:D-0482-2022

Official wording

Reason: cGMP deviations

Code information: Lot #: K9770, AK9770 Exp. Date 08/2022; AK9958, K9958 Exp. Date 12/2022; AK9717, Exp. Date 07/2022; AK9522, AK9641 , Exp. Date 03/2022; AK9817, Exp. Date 09/2022

Distribution pattern: Nationwide within the United States

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    cGMP deviations