Class II · Moderate risk
Telmisartan Tablets
Failed Stability Specifications: Out of specification for blend uniformity.
Telmisartan Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
What was recalled
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.
Affected NDC
13668-0158-72
Compare with the code on your package — it is the most precise check available.
Drug: Telmisartan Category: Blood Pressure Medication
- Recalling firm
- Torrent Pharmaceuticals Limited
- NDC code
- 13668-158-72
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0824-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Telmisartan recalls
See all
Class II · Moderate risk
Telmisartan and Hydrochlorothiazide Tablets USP
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Class II · Moderate risk
Telmisartan and Hydrochlorothiazide Tablets USP
Defective Container: Recall of these batches has been initiated due to complaints of difficult to open blister and tablet breaks while opening the blister .
Class III · Low risk
Telmisartan and Hydrochlorothiazide Tablets
Superpotent; Hydrochlorothiazide
Class II · Moderate risk
Micardis Tablets
Subpotent Drug
Other particulate / foreign matter recalls from 2016
All particulate / foreign matter recalls
Class III · Low risk
Pentasa (mesalamine)
Presence of Foreign Tablets/Capsules; 500 mg capsules were found in bottles labeled to contain 250 mg capsules
Class II · Moderate risk
Metformin Hydrochloride Tablets
Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP
Class III · Low risk
AHP NIFEdipine Capsules
Presence of Foreign Tablets/Capsules
Class III · Low risk
NIFEdipine Capsules USP
Presence of Foreign Tablets/Capsules
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