Recalls / Class II
Class IID-0517-2024
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
- Brand name
- Metoprolol Tartrate
- Generic name
- Metoprolol Tartrate
- Active ingredient
- Metoprolol Tartrate
- Route
- Oral
- NDCs
- 52817-358, 52817-362, 52817-359, 52817-361, 52817-360
- FDA application
- ANDA200981
- Affected lot / code info
- Lot 231037H1, exp 6/2027
Why it was recalled
Presence of Foreign Substance: metal in tablet
Recalling firm
- Firm
- Rubicon Research Private Limited
- Manufacturer
- TruPharma LLC
- Type
- Voluntary: Firm initiated
- Address
- 4 & K30 5 Plot No K - 30, District, Ambarnath, N/A, India
Distribution
- Quantity
- 11,664 Bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2024-05-06
- FDA classified
- 2024-05-29
- Posted by FDA
- 2024-06-05
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0517-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.