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

Recall Number: D-1494-2022

Firm: Plastikon Healthcare LLC

Classification: Class II

Status: Terminated

Report Date: 20220914

Initiation Date: 20220607

Termination Date: 20250625

Reason for Recall

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

Product Description

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