Plastikon Healthcare LLC recalls CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 160 mg per 5 mL), 2.04 FL.OZ (60mL), package
Recalled September 14, 2022 · FDA recall D-1493-2022 · Plastikon Healthcare
Hazard
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled. · FDA Class II
Units
1,464 ampoules
Sold at
Distributed Nationwide in the USA
Description
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Product
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
Manufacturer(s)
Plastikon Healthcare LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →