D-0824-2016 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- April 27, 2016
- Initiation Date
- February 25, 2016
- Termination Date
- June 3, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 20,952 cartons
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.
Reason for Recall
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
Distribution Pattern
Nationwide
Code Information
Lot#: BBV8B002R, Exp 12/16