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Recall Observatory FDA recall evidence

Drug product

Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316 6

D-0389-2022

December 06, 2021

Class II

Product summary

Firm
Medique Products
Event
Event 89356
Status
Terminated
Classification
Class II
Quantity
3,260,400 tablets
Official record key
drug-enforcement:D-0389-2022

Official wording

Reason: CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.

Code information: Lots: (Packet, Carton) 6151, 4360 Exp. 10/2021; 6240, 4446 Exp. 12/2021; 6331, 4484 Exp. 02/2022; 6413, 4551 Exp. 04/2022; 6699, 4679 Exp. 10/2022; 6751, 4714 Exp. 12/2022; 6855, 4750 Exp. 01/2023; 6868, 4761 Exp. 02/2023; 6899, 4776 Exp. 02/2023; 6899, 4776 Exp. 02/2023; 7061, 4821 Exp. 05/2023.

Distribution pattern: Nationwide in the USA

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations