Recalls / Class II
Class IID-0362-2022
Product
Metoprolol Tartrate Tablets, USP 25 mg, 1000 - count bottle, Rx Only, Distributed by: TruPharma, LLC. Tampa, FL 33609; Manufactured by: Rubicon Research Prvate 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
- Batch # 210211H1, Exp. date FEB 2024
Why it was recalled
Complaint received of foreign matter (metal) embedded in tablet.
Recalling firm
- Firm
- Rubicon Research Private Limited
- Manufacturer
- TruPharma LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 4 & K 30 5 Plot No K 30, N/A, Ambernath, N/A N/A, India
Distribution
- Quantity
- 3,684 1000-count bottles
- Distribution pattern
- Product was distributed to one distributor who may have distributed the product further nationwide.
Timeline
- Recall initiated
- 2021-12-31
- FDA classified
- 2022-01-07
- Posted by FDA
- 2022-01-19
- Terminated
- 2022-11-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0362-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.