Recalls / Class III
Class IIID-1167-2014
Product
Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10
- Affected lot / code info
- Lot #: 91357
Why it was recalled
Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval.
Recalling firm
- Firm
- McKesson Packaging Services
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7101 Weddington Rd NW, Concord, North Carolina 28027-3412
Distribution
- Quantity
- 1,557 Boxes
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2014-03-03
- FDA classified
- 2014-03-18
- Posted by FDA
- 2014-03-26
- Terminated
- 2014-08-14
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1167-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.