Recalls / Class I
Class ID-1395-2019
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.
- Brand name
- Pecgen Dmx
- Generic name
- Dextromethorphan Hbr, Guaifenesin
- Active ingredients
- Dextromethorphan Hydrobromide, Guaifenesin
- Route
- Oral
- NDC
- 52083-630
- FDA application
- M012
- Affected lot / code info
- Lot #s: D80202, D80210 Exp. 02/20; D80818, D80819 Exp. 09/20; D80820 Exp. 09/20
Why it was recalled
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.
Recalling firm
- Firm
- Novis PR, Inc.
- Manufacturer
- KRAMER NOVIS
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 320 Ave Barbosa, N/A, San Juan, Puerto Rico 00917-4315
Distribution
- Quantity
- 5766 bottles
- Distribution pattern
- Puerto Rico
Timeline
- Recall initiated
- 2019-05-28
- FDA classified
- 2019-06-19
- Posted by FDA
- 2019-06-19
- Terminated
- 2021-02-10
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1395-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.