CORRECTDOSE Children's PAIN RELIEF & Fever Reducer recalled over manufacturing violations

Recall date

June 7, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Plastikon Healthcare LLC recalls CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), package…

Recall number

D-1493-2022

FDA classification

Class II

Brand / firm

Plastikon Healthcare LLC

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

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