Recalls / Class I
Class ID-0868-2023
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Brand name
- G-supress Dx
- Generic name
- Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
- Active ingredients
- Dextromethorphan Hydrobromide, Guaifenesin, Phenylephrine Hydrochloride
- Route
- Oral
- NDC
- 52083-655
- FDA application
- M012
- Affected lot / code info
- Lot: D20911, Exp. Oct/25
Why it was recalled
Product mix-up: incorrect product was found inside the G-Supress DX product carton.
Recalling firm
- Firm
- Novis PR, LLC dba Kramer Novis
- Manufacturer
- KRAMER NOVIS
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 320 Ave Barbosa, N/A, San Juan, Puerto Rico 00917-4315
Distribution
- Quantity
- 9077 bottles
- Distribution pattern
- Puerto Rico
Timeline
- Recall initiated
- 2023-04-20
- FDA classified
- 2023-06-06
- Posted by FDA
- 2023-06-07
- Terminated
- 2024-09-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0868-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.