FDA-Drug2022-09-14Class II
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
Plastikon Healthcare LLC
Hazard
CGMP Deviations: products manufactured under conditions which reflect manufacturing processes that were not adequately controlled.
Sold states
Distributed Nationwide in the USA
Affected count
1,464 ampoules
Manufactured in
3780 Greenway Cir, N/A, Lawrence, KS, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1494-2022Don't want to check this manually?
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