Why it was recalled
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Product description
G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant, Cherry Flavor Sugar & Alcohol Free, packaged in a bottle Net Content: 30 mL (1 oz.) further packaged in a carton, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-655-01
Lot numbers, UPCs & expiration codes
Lot: D20911, Exp. Oct/25
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-0868-2023
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 20, 2023
- FDA report date
- Jun 7, 2023
- Quantity
- 9077 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Novis PR, LLC dba Kramer Novis
Original FDA data
Every field from FDA enforcement report D-0868-2023, exactly as published.
Show all FDA fields
- City
- San Juan
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 92324
- Address
- 320 Ave Barbosa
- Code information
- Lot: D20911, Exp. Oct/25
- Postal code
- 00917-4315
- Report date
- Jun 7, 2023
- Product type
- Drugs
- Recall number
- D-0868-2023
- Classification
- Class I
- Recalling firm
- Novis PR, LLC dba Kramer Novis
- Product quantity
- 9077 bottles
- Termination date
- Sep 13, 2024
- Reason for recall
- Product mix-up: incorrect product was found inside the G-Supress DX product carton.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant, Cherry Flavor Sugar & Alcohol Free, packaged in a bottle Net Content: 30 mL (1 oz.) further packaged in a carton, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-655-01
- Distribution pattern
- Puerto Rico
- Recall initiation date
- Apr 20, 2023
- Initial firm notification
- Letter
- Center classification date
- Jun 6, 2023