FDA-Drug2026-10-16Class III

Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA, Made in India, NDC 0378-1075-93.

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Hazard

Superpotent Drug: potential for the Telmisartan content in these lots to exceed specifications

Sold states
Nationwide in the USA.
Affected count
21,620 30-count bottles
Manufactured in
3711 Collins Ferry Rd, Morgantown, West Virginia, United States
Products
Telmisartan and Amlodipine, Tablets, USP, 40mg/5 mg, 30-count Bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 USA, Made in India, NDC 0378-1075-93.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0049-2027

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