US Drug Recall Register
Class II · Moderate risk Terminated Initiated Jun 7, 2022 (4 years ago)

CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.

What was recalled

CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), packaged in 12-5mL individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-311-05 UPC 8 60003 67145 0

Recalling firm
Plastikon Healthcare LLC
NDC code
62320-311-05
Origin
KS, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1493-2022

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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