PlainRecalls
FDA Drug Moderate Class II Terminated

Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832

Reported: February 9, 2022 Initiated: January 24, 2022 #D-0482-2022

Product Description

Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832

Reason for Recall

cGMP deviations

Details

Recalling Firm
Ultra Seal Corporation
Units Affected
5,107,565 packets
Distribution
Nationwide within the United States
Location
New Paltz, NY

Frequently Asked Questions

What product was recalled?
Backache & Muscle Relief (acetaminophen 250 mg, magnesium salicylate-tetrahydrate 290mg, caffeine 50 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 42961-111-832. Recalled by Ultra Seal Corporation. Units affected: 5,107,565 packets.
Why was this product recalled?
cGMP deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on February 9, 2022. Severity: Moderate. Recall number: D-0482-2022.