FDAOctober 26, 2021drug

Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1321-97

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

The hazard

CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.

What to do

FDA enforcement status: Terminated

Brands named

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Recall history

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

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Children's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1321-97 — Recall Details · AllClear