Why it was recalled
Presence of Foreign Substance: metal in tablet
Product description
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
Lot numbers, UPCs & expiration codes
Lot 231037H1, exp 6/2027
Where it was sold
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-0517-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 6, 2024
- FDA report date
- Jun 5, 2024
- Quantity
- 11,664 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rubicon Research Private Limited
Original FDA data
Every field from FDA enforcement report D-0517-2024, exactly as published.
Show all FDA fields
- City
- Ambarnath
- Status
- Ongoing
- Country
- India
- Event ID
- 94542
- Address
- 4 & K30 5 Plot No K - 30
- Address (line 2)
- District
- Code information
- Lot 231037H1, exp 6/2027
- Report date
- Jun 5, 2024
- Product type
- Drugs
- Recall number
- D-0517-2024
- Classification
- Class II
- Recalling firm
- Rubicon Research Private Limited
- Product quantity
- 11,664 Bottles
- Reason for recall
- Presence of Foreign Substance: metal in tablet
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide
- Recall initiation date
- May 6, 2024
- Center classification date
- May 29, 2024