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FDAFDA · Food and drugs·Recall number D-1494-2022

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

Published September 14, 2022 · Recall initiated: June 7, 2022

Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.

What's the hazard

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

What to do

Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit

Recall details

Manufacturer
Plastikon Healthcare LLC
Distributor
Distributed Nationwide in the USA
Lot
Lot # 21014A, EXP Feb. 2023
Risk classification
Class II
Area (FDA)
drug
Country
United States

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