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.
Product description
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 numbers, UPCs & expiration codes
Lot #s: D80202, D80210 Exp. 02/20; D80818, D80819 Exp. 09/20; D80820 Exp. 09/20
Where it was sold
Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1395-2019
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- May 28, 2019
- FDA report date
- Jun 19, 2019
- Quantity
- 5766 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novis PR, Inc.
Original FDA data
Every field from FDA enforcement report D-1395-2019, exactly as published.
Show all FDA fields
- City
- San Juan
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 82968
- Address
- 320 Ave Barbosa
- Code information
- Lot #s: D80202, D80210 Exp. 02/20; D80818, D80819 Exp. 09/20; D80820 Exp. 09/20
- Postal code
- 00917-4315
- Report date
- Jun 19, 2019
- Product type
- Drugs
- Recall number
- D-1395-2019
- Classification
- Class I
- Recalling firm
- Novis PR, Inc.
- Product quantity
- 5766 bottles
- Termination date
- Feb 10, 2021
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Puerto Rico
- Recall initiation date
- May 28, 2019
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jun 19, 2019