Plastikon Healthcare LLC recalls CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60m
Recalled September 14, 2022 · FDA recall D-1494-2022 · 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 COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dextromethorphan 5 mg per 5 mL) 2.04FL. OZ (60mL), packaged in 12-5 individual doses, Distributed by Correct Dose Inc, Braintree MA 02184. NDC 62320-321-05 UPC 8 60003 67146 7
Manufacturer(s)
Plastikon Healthcare LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →