FDA-Drug2019-03-20Class II

Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd. Baddi, Himchal Pradesh INDIA, NDC 33342-128-07

Macleods Pharma Usa Inc
Hazard

Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.

Sold states
Nationwide within the United States
Affected count
93227 bottles
Manufactured in
666 Plainsboro Rd Bldg 200 Ste 230, N/A, Plainsboro, NJ, United States
Products
Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd. Baddi, Himchal Pradesh INDIA, NDC 33342-128-07

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1003-2019

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