PlainRecalls
FDA Drug Moderate Class II Terminated

Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00

Reported: February 16, 2022 Initiated: January 26, 2022 #D-0547-2022

Product Description

Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00

Reason for Recall

CGMP Deviations

Details

Units Affected
990,197 tablets
Distribution
Bulk product was distributed to 3 distributors who may have distributed finished product.
Location
Highland, NY

Frequently Asked Questions

What product was recalled?
Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-565-00. Recalled by ULTRAtab Laboratories, Inc.. Units affected: 990,197 tablets.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on February 16, 2022. Severity: Moderate. Recall number: D-0547-2022.