FDA Recall D-1395-2019

Novis PR, Inc. · San Juan, PR

Class I — life-threatening Terminated 624 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

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.

Lot / code: Lot #s: D80202, D80210 Exp. 02/20; D80818, D80819 Exp. 09/20; D80820 Exp. 09/20

Quantity: 5766 bottles

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.

Recall record

Recall number: D-1395-2019
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution: Puerto Rico
Recall initiated: 2019-05-28
Classified by FDA Center: 2019-06-19
FDA published: 2019-06-19
Terminated: 2021-02-10
Recalling firm: Novis PR, Inc.
Firm location: San Juan, PR

Drug identification

Brand name(s): PECGEN DMX
Generic name(s): DEXTROMETHORPHAN HBR, GUAIFENESIN
Manufacturer(s): KRAMER NOVIS
NDC(s): 52083-630
Route(s): ORAL

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