FDA-Drug2022-02-16Class II
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx
ULTRAtab Laboratories, Inc.
Hazard
CGMP Deviations
Sold states
Bulk product was distributed to 3 distributors who may have distributed finished product.
Affected count
1,798,048 tablets
Manufactured in
50 Toc Dr, N/A, Highland, NY, United States
Products
Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-111-xx
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0525-2022Don't want to check this manually?
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