Why it was recalled
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
Product description
Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, Dist. Mehsana, INDIA.; For: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, NDC 13668-158-72, UPC 3 13668 158 72 4.
Lot numbers, UPCs & expiration codes
Lot#: BBV8B002R, Exp 12/16
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-0824-2016
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 25, 2016
- FDA report date
- Apr 27, 2016
- Quantity
- 20,952 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Torrent Pharmaceuticals Limited
Original FDA data
Every field from FDA enforcement report D-0824-2016, exactly as published.
Show all FDA fields
- City
- Kadi
- Status
- Terminated
- Country
- India
- Event ID
- 73466
- Address
- Ahmedabad Mehsana Highway
- Code information
- Lot#: BBV8B002R, Exp 12/16
- Report date
- Apr 27, 2016
- Product type
- Drugs
- Recall number
- D-0824-2016
- Classification
- Class III
- Recalling firm
- Torrent Pharmaceuticals Limited
- Product quantity
- 20,952 cartons
- Termination date
- Jun 3, 2016
- Reason for recall
- Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Telmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, Dist. Mehsana, INDIA.; For: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, NDC 13668-158-72, UPC 3 13668 158 72 4.
- Distribution pattern
- Nationwide
- Recall initiation date
- Feb 25, 2016
- Initial firm notification
- Letter
- Center classification date
- Apr 18, 2016