Pecgen DMX Cough Suppressant Expectorant, Contains the same active ingredients as Trispec DMX, Sugar Free, Alcohol Free, Dye Free, Gluten Free, Cherry Raspberry Flavor, 16 Fl. oz. (474 mL), Manufactured in the USA for Kramer Novis, San Juan, PR 00917, www.kramernovis.com, NDC 52083-630-16.
Check against the official notice below — it lists the full affected range.
Pecgen DMX Cough Suppressant Expectorant, a cherry raspberry-flavored liquid product sold in Puerto Rico, has been recalled due to labeling errors on its drug facts label. The label incorrectly states the product is for children 6 to under 2 years of age when it should state children 6 to under 12 years of age. Additionally, the label fails to advise consumers to consult a doctor before giving the product to children under 2 years of age. The recall affects approximately 5,766 bottles with lot numbers D80202, D80210, D80818, D80819, and D80820, with expiration dates between February 2020 and September 2020.
The source document does not specify a remedy for consumers who possess this product.
Written by software from the official notice below. Not reviewed by a lawyer.
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 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age.
Reason for recall: 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 4 hours, not to exceed 4 teaspoonfuls in 24 hours or directed by physician. The label should state children 6 to under 12, 1 teaspoonful every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as directed by physician. Additionally, the label does not advise consumers to consult a doctor for children under 2 years of age. Distribution: Puerto Rico Quantity: 5766 bottles Lot/code info: Lot #s: D80202, D80210 Exp. 02/20; D80818, D80819 Exp. 09/20; D80820 Exp. 09/20
Official record: FDA (Drug enforcement) ↗
Republished from the official source above; details can change — the source record controls.