Why it was recalled
Complaint received of foreign matter (metal) embedded in tablet.
Product description
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
Lot numbers, UPCs & expiration codes
Batch # 210211H1, Exp. date FEB 2024
Where it was sold
Product was distributed to one distributor who may have distributed the product further nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0362-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 31, 2021
- FDA report date
- Jan 19, 2022
- Quantity
- 3,684 1000-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rubicon Research Private Limited
Original FDA data
Every field from FDA enforcement report D-0362-2022, exactly as published.
Show all FDA fields
- City
- Ambernath
- Status
- Terminated
- Country
- India
- Event ID
- 89311
- Address
- 4 & K 30 5 Plot No K 30
- Code information
- Batch # 210211H1, Exp. date FEB 2024
- Report date
- Jan 19, 2022
- Product type
- Drugs
- Recall number
- D-0362-2022
- Classification
- Class II
- Recalling firm
- Rubicon Research Private Limited
- Product quantity
- 3,684 1000-count bottles
- Termination date
- Nov 4, 2022
- Reason for recall
- Complaint received of foreign matter (metal) embedded in tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Product was distributed to one distributor who may have distributed the product further nationwide.
- Recall initiation date
- Dec 31, 2021
- Initial firm notification
- Letter
- Center classification date
- Jan 7, 2022