San Juan, PR, United States
Novis PR, LLC dba Kramer Novis recalls
3 recalls recorded since 2018, most recently on 20 April 2023. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)1
Terminated Class I Drugs
- Recall started
- 20 April 2023
- Terminated
- 13 September 2024
- Reason
- Product mix-up: incorrect product was found inside the G-Supress DX product carton.
- Distribution
- Puerto Rico
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0868-2023
- 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.) fu
Terminated Class II Food
- Recall started
- 27 March 2023
- Terminated
- 15 August 2023
- Reason
- Bloated Protein Bottle
- Distribution
- Domestic distribution only.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- F-0810-2023, F-0811-2023, F-0812-2023
- GPre Protein, Liquid predigested Protein, Dietary Supplement, Nt Wt. 16 oz, plastic bottle packed 12 units of 16 oz in 1 case.
- PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 30 mL pouch, packed 200 units of 30mL in 1 case
- PreProtein, Liquid Predigested Protein, Dietary Supplement, Nt Wt. 16 oz Bottle, packed in 12 units of 16 oz. each per case.
Terminated Class III Food
- Recall started
- 25 August 2022
- Terminated
- 14 December 2022
- Reason
- Physical appearance of bottle of G-Pre Protein was atypical. Once opened, unusual odor was noticed and atypical bubbles were present.
- Distribution
- Domestic distribution only (Puerto Rico).
- Initiated
- Voluntary: Firm initiated
- Recall number
- F-0037-2023
- G-PREPROTEIN, Liquid Predigested Protein, Dietary Supplement, Cherry Flavor, Net Contents 16 fl oz (473 mL), Kramer Novis
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.