Why it was recalled
Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
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.
Lot numbers, UPCs & expiration codes
Lot # N03029, Exp 03/14
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-193-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 23, 2013
- FDA report date
- Mar 20, 2013
- Quantity
- 3,913 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
Original FDA data
Every field from FDA enforcement report D-193-2013, exactly as published.
Show all FDA fields
- City
- Sellersville
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 64233
- Address
- 650 Cathill Rd
- Code information
- Lot # N03029, Exp 03/14
- Postal code
- 18960-1512
- Report date
- Mar 20, 2013
- Product type
- Drugs
- Recall number
- D-193-2013
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA, Inc.
- Product quantity
- 3,913 bottles
- Termination date
- Apr 3, 2014
- Reason for recall
- Presence of Foreign Tablets/Capsules: Recall is being conducted due to a foreign capsule found in one bottle.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 23, 2013
- Initial firm notification
- Letter
- Center classification date
- Mar 8, 2013