PlainRecalls
FDA Drug Moderate Class II Terminated

CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

Reported: February 9, 2022 Initiated: January 24, 2022 #D-0511-2022

Product Description

CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124

Reason for Recall

cGMP deviations

Details

Recalling Firm
Ultra Seal Corporation
Units Affected
1,019,000 packets
Distribution
Nationwide within the United States
Location
New Paltz, NY

Frequently Asked Questions

What product was recalled?
CETAFEN Extra Non-Aspirin Pain Relieve (Acetaminophen 500 mg) caplets, 2-count packets, Manufactured for: HARTHealth Seattle, WA 98124. Recalled by Ultra Seal Corporation. Units affected: 1,019,000 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-0511-2022.