Drug product
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.
D-0824-2016
Product summary
- Event
- Event 73466
- Status
- Terminated
- Classification
- Class III
- Quantity
- 20,952 cartons
- Official record key
drug-enforcement:D-0824-2016
Official wording
Reason: Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
Code information: Lot#: BBV8B002R, Exp 12/16
Distribution pattern: Nationwide
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance