Home / Recalls / Medique Products / D-0389-2022

D-0389-2022 Class II Terminated

Recalled by Medique Products — Fort Myers, FL

Recall Details

Product Type: Drugs
Report Date: January 26, 2022
Initiation Date: December 6, 2021
Termination Date: June 21, 2023
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,260,400 tablets

Product Description

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

Reason for Recall

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

Distribution Pattern

Nationwide in the USA

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.