PlainRecalls
FDA Drug Moderate Class II Terminated

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.

Reported: March 20, 2013 Initiated: January 23, 2013 #D-193-2013

Product Description

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.

Details

Units Affected
3,913 bottles
Distribution
Nationwide
Location
Sellersville, PA

Frequently Asked Questions

What product was recalled?
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.. Recalled by Teva Pharmaceuticals USA, Inc.. Units affected: 3,913 bottles.
Why was this product recalled?
Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
Which agency issued this recall?
This recall was issued by the FDA Drug on March 20, 2013. Severity: Moderate. Recall number: D-193-2013.