FDA Recall D-0229-2024
Pharma Nobis LLC · Texarkana, TX
Class II Ongoing 875 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
CVS Health Magnesium Citrate Saline Laxative Oral Solution DYE FREE Grape Flavor 10 fl. oz, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895, NDC 51316-881-10.
Reason for recall
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Recall record
- Recall number
D-0229-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Distribution
- Nationwide.
- Recall initiated
- 2023-12-21
- Classified by FDA Center
- 2024-01-12
- FDA published
- 2024-01-24
- Recalling firm
- Pharma Nobis LLC
- Firm location
- Texarkana, TX
Drug identification
- Brand name(s)
- MAGNESIUM CITRATE
- Generic name(s)
- CVS MAGNESIUM CITRATE ORAL SOLUTION - GRAPE
- Manufacturer(s)
- CVS Pharmacy, Inc.
- NDC(s)
51316-881- Route(s)
- ORAL
Operational response
Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.
For the official FDA enforcement record, see FDA's Recall Search.