Class III
Terminated
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.
This recall has been terminated (originally issued April 27, 2016).
- Company
- Torrent Pharmaceuticals Limited
- Recall Initiated
- February 25, 2016
- Posted
- April 27, 2016
- Recall Number
- D-0824-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 20,952 cartons
- Firm Location
- Kadi, India
- Official Source
- View on FDA website ↗
Reason for Recall
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
Distribution
Nationwide
Lot / Code Info
Lot#: BBV8B002R, Exp 12/16
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