FDA-Drug2022-02-16Class II
APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00
ULTRAtab Laboratories, Inc.
Hazard
CGMP Deviations
Sold states
Bulk product was distributed to 3 distributors who may have distributed finished product.
Affected count
14,349,148 tablets
Manufactured in
50 Toc Dr, N/A, Highland, NY, United States
Products
APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-140-00
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0530-2022Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief