FDA-Drug2022-02-16Class II
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00
ULTRAtab Laboratories, Inc.
Hazard
CGMP Deviations
Sold states
Bulk product was distributed to 3 distributors who may have distributed finished product.
Affected count
33,758,436 tablets
Manufactured in
50 Toc Dr, N/A, Highland, NY, United States
Products
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0523-2022Don't want to check this manually?
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