FDA recall D-1352-2015

Product

Hydrochlorothiazide Tablet USP 25 mg,1000- count bottle, Rx Only, Manufactured by: UNICHEM LABORATORIES LTD. Pilerne Ind. Estate, Pilerne, Bardez, Goa 403 511, India Marketed by: UNICHEM PHARMACEUTICALS (USA), INC. Rochelle Park, NJ 07662, NDC 29300-128-10

Reason for recall

Presence of Foreign Tablet: A pharmacist found a clopidogrel tablet in the 1000-count bottle of hydrochlorothiazide 25 mg tablets.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-07-30

Report date

2015-09-02

Termination date

2018-10-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Rochelle Park, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1352-2015