Novis PR, LLC dba Kramer Novis: Drug Recall
Recall #D-0868-2023 · 04/20/2023
Class I: Dangerous
Recall Details
- Recall Number
- D-0868-2023
- Classification
- Class I
- Product Type
- Drug
- Recalling Firm
- Novis PR, LLC dba Kramer Novis
- Status
- Terminated
- Date Initiated
- 04/20/2023
- Location
- San Juan, PR, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9077 bottles
Reason for Recall
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
Distribution Pattern
Puerto Rico
Other Recalls by Novis PR, LLC dba Kramer Novis
- Class II: Risk 03/27/2023
- Class II: Risk 03/27/2023
- Class II: Risk 03/27/2023
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.