FDA recall D-1004-2019

Product

Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Imachal Pradesh, India NDC 33342-129-07

Reason for recall

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

Distribution

Nationwide within the United States

Key facts

Status

Terminated

Initiation date

2019-02-25

Report date

2019-03-20

Termination date

2021-07-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plainsboro, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1004-2019