Recalls / Class II
Class IID-1183-2014
Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 30 Capsules per Bottle, Manufactured in Israel by: Teva Pharmaceutical IND, LTD, Jerusalem, Israel, Manufactured for: Teva Pharmaceuticals USA, Sellersville, PA, 18960, NDC 0093-7543-56
- Affected lot / code info
- Lot #: 49D001, Exp. 4/2015; 49D002, Exp. 6/2015; 49D003, Exp. 7/2015; 49D004, 49D005, 49D006, Exp. 9/2015; 49D007, Exp. 10/2015
Why it was recalled
Failed Tablet/Capsule Specifications: Teva Pharmaceuticals USA, is voluntarily recalling certain lots of Duloxetine DR Capsules USP, 20 mg, 30 mg & 60 mg due to a customer complaint trend regarding capsule breakage.
Recalling firm
- Firm
- Teva Pharmaceuticals USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 425 Privet Rd, N/A, Horsham, Pennsylvania 19044-1220
Distribution
- Quantity
- 598,033 Bottles
- Distribution pattern
- Nationwide, Guam, Puerto Rico, American Samoa, Virgin Islands.
Timeline
- Recall initiated
- 2014-03-04
- FDA classified
- 2014-04-01
- Posted by FDA
- 2014-04-09
- Terminated
- 2014-11-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1183-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.