Agency classClass IIOur severity:High FDA (Drugs)·D-1494-2022·Announced 2022-09-14

Children's Cough Medicine Recalled for Manufacturing Control Deficiency

CORRECTDOSE Children's Cough & Chest Congestion DM is being recalled nationwide due to manufacturing process control deviations that did not meet required quality standards.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a children's medication where manufacturing processes were not adequately controlled under Current Good Manufacturing Practice standards. While no illnesses or injuries have been reported, this represents a risk-of-harm product in a vulnerable population, consistent with a 'High' severity rating per the rubric criteria for potential harm without confirmed injury.

Plain-English summary

CORRECTDOSE Children's Cough & Chest Congestion DM is being recalled nationwide. This combination medicine contains Guaifenesin 100 mg and Dextromethorphan 5 mg per 5 mL dose and is packaged as 2.04 FL OZ (60 mL) with 12 individual doses. The affected lot is lot number 21014A with expiration date of February 2023 (NDC 62320-321-05). Approximately 1,464 ampoules were distributed nationwide by Correct Dose Inc. of Braintree, Massachusetts. The product was manufactured by Plastikon Healthcare LLC.

The recall was issued because the product was manufactured under conditions that did not meet Current Good Manufacturing Practice (CGMP) standards. Manufacturing processes were not adequately controlled, raising concerns about product quality and safety.

Consumers who have purchased this product should stop using it immediately. Anyone who has concerns about their use of this medicine should consult with their healthcare provider. The product should be disposed of appropriately or returned to the place of purchase.

The recalled product

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: Plastikon Healthcare LLC
Category: Drug — Pediatric Cough & Cold Medicine
Hazard: manufacturing-control-deficiency
Affected units: 1,464

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot # 21014A
EXP Feb. 2023

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 19 recalled by Plastikon Healthcare LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 19 products in this recall →

Same manufacturer · Plastikon Healthcare LLC

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Same hazard · manufacturing control deficiency