FDA recall D-193-2013

Product

Terazosin Hydrochloride Capsules, 2 mg, packaged in a) 100-count bottles (NDC 0093-4337-01); and b) 1000-count bottles (NDC 0093-4337-10), Rx only, Manufactured in India By: Intas Pharmaceuticals Ltd., Ahmedabad, Gujarat, India - 382 210; Manufactured For: Teva Pharmaceuticals USA, Sellersville, PA 18960.

Reason for recall

Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2013-01-23

Report date

2013-03-20

Termination date

2014-04-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Sellersville, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-193-2013