Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, pack
Summary
The FDA issued a Class II for Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), an by Medique Products. Reason: CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practi.
Details
Source
Drug Recall
External ID
D-0389-2022
Action Date
2022-01-26
Status
Terminated
Category
drug
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
Lot/Code Info: 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.
Quantity Affected: 3,260,400 tablets
Reason for Recall
CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not manufactured under Current Good Manufacturing Practices.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2021-12-06
Company
Fort Myers, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 44 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Medique Products has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Medique Products) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Medique Products have FDA actions?
Medique Products has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0389-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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