FDA Recall D-0868-2023
Novis PR, LLC dba Kramer Novis · San Juan, PR
Class I — life-threatening Terminated 512 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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
Reason for recall
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Recall record
- Recall number
D-0868-2023- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Puerto Rico
- Recall initiated
- 2023-04-20
- Classified by FDA Center
- 2023-06-06
- FDA published
- 2023-06-07
- Terminated
- 2024-09-13
- Recalling firm
- Novis PR, LLC dba Kramer Novis
- Firm location
- San Juan, PR
Drug identification
- Brand name(s)
- G-SUPRESS DX
- Generic name(s)
- DEXTROMETHORPHAN HYDROBROMIDE, GUAIFENESIN, PHENYLEPHRINE HYDROCHLORIDE
- Manufacturer(s)
- KRAMER NOVIS
- NDC(s)
52083-655- Route(s)
- ORAL