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FDAJanuary 26, 2022drug

Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

CGMP Deviations

What to do

FDA enforcement status: Terminated

Brands named

ultratab laboratoriesultratab

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-124-00 — Recall Details · AllClear