FDAClass IIJanuary 26, 2022

Physicians CARE Extra Strength PAIN RELIEVER recall: CGMP Deviations

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

Why was Physicians CARE Extra Strength PAIN RELIEVER recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

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
Recalling firm
Medique Products
Quantity
3,260,400 tablets
Distribution
Nationwide in the USA
Recall date
January 26, 2022
Classification
Class II
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls