Pecgen DMX Recalled for Incorrect Pediatric Dosage Labeling
Novis PR, Inc. is recalling Pecgen DMX cough syrup because a typo on the label provides incorrect dosage instructions for children.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this recall as Class I — a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "Labeling: Incorrect Instructions; The product has been found to provide incorrect dosage information on its label due to a typographical error. The drug facts label incorrectly states children 6 to under 2 years of age, 1 teaspoonful every…"
Plain-English summary
Novis PR, Inc. is recalling 5,766 bottles of Pecgen DMX (Dextromethorphan HBr, Guaifenesin) cough suppressant and expectorant. The product was distributed in Puerto Rico. The recall involves specific lots with expiration dates of 02/20 and 09/20.
The recall was initiated due to a typographical error on the drug facts label that provides incorrect dosage information for children. The label incorrectly states that children 6 to under 2 years of age should take 1 teaspoonful every 4 hours. The correct instruction should state that children 6 to under 12 years of age should take 1 teaspoonful every 4 hours. Additionally, the label fails to advise consumers to consult a doctor for children under 2 years of age.
Consumers with this product should stop using it and return it to the point of purchase or contact the manufacturer for instructions.
The recalled product
- Product
- PECGEN DMX (DEXTROMETHORPHAN HBR, GUAIFENESIN)
- Brand
- PECGEN DMX
- Manufacturer
- Novis PR, Inc.
- Category
- Drug — OTC Cough Medicine
- Affected units
- 5,766
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 (5)
- Lot #s: D80202
- D80210 Exp. 02/20
- D80818
- D80819 Exp. 09/20
- D80820 Exp. 09/20
UPCs (1)
- 0352083630163
Distribution
Distributed in 1 state:
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