FDA Recall D-0517-2024
Rubicon Research Private Limited
Class II Ongoing 738 days on record
Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.
Product
Metoprolol Tartrate Tablets USP, 25mg, 1000 count bottle, Rx only, distributed by: TruPharma, LLC, Tampa, FL 33609, Manufactured by: Rubicon Research Private Limited, Ambernath Dist Thane 421506 India, NDC 52817-360-00
Reason for recall
Presence of Foreign Substance: metal in tablet
Recall record
- Recall number
D-0517-2024- Classification
- Class II
- Status
- Ongoing
- Voluntary or mandated
- Voluntary: Firm initiated
- Distribution
- Nationwide
- Recall initiated
- 2024-05-06
- Classified by FDA Center
- 2024-05-29
- FDA published
- 2024-06-05
- Recalling firm
- Rubicon Research Private Limited
Drug identification
- Brand name(s)
- METOPROLOL TARTRATE
- Generic name(s)
- METOPROLOL TARTRATE
- Manufacturer(s)
- TruPharma LLC
- NDC(s)
52817-358, 52817-362, 52817-359, 52817-361, 52817-360- 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.