Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
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.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Failed Stability Specifications: Out of specification for blend uniformity.
Reason Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the…
Reason Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the…
Reason Superpotent; Hydrochlorothiazide
Reason Subpotent Drug
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