FDA-Drug2013-03-20Class II

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.

Teva Pharmaceuticals USA, Inc.
Hazard

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

Sold states
Nationwide
Affected count
3,913 bottles
Manufactured in
650 Cathill Rd, N/A, Sellersville, PA, United States
Products
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.

Official notice

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

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