FDA recall D-1177-2018

Product

AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90

Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-07-18

Report date

2018-09-12

Termination date

2020-05-07

Voluntary/Mandated

Voluntary: Firm initiated

Location

Pulaski, TN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1177-2018