Physicians CARE Extra Strength Pain Reliever recalled for CGMP deviations
Medique Products is recalling Physicians CARE Extra Strength Pain Reliever tablets nationwide because they were not manufactured under Current Good Manufacturing Practices (CGMP), as determined by an FDA inspection.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing compliance deviation without evidence of actual product harm. This falls under the Moderate category for precautionary recalls related to manufacturing control issues.
Plain-English summary
Medique Products is recalling Physicians CARE Extra Strength Pain Reliever, a combination pain reliever containing acetaminophen (250 mg), aspirin (250 mg), and caffeine (65 mg). The product is sold in 100-count tablet cartons containing 50 packets of 2 tablets each, with UPC 0 73577 90316 6, manufactured for Acme United Corporation in Fairfield, Connecticut.
The recall was initiated after an FDA inspection identified that the product was not manufactured under Current Good Manufacturing Practices (CGMP). A total of 3,260,400 tablets across multiple lots with expiration dates ranging from October 2021 through May 2023 have been distributed nationwide in the USA.
Consumers who have purchased this product should stop using it. Affected lot and carton code numbers are listed in the FDA recall notice. Consumers with questions about the recall should contact the manufacturer or the FDA.
The recalled product
- 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
- Manufacturer
- Medique Products
- Hazard
- cgmp-deviation
- manufacturing-control
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
- 7061
Distribution
Distributed nationwide across the United States.
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