Recalls / Class III
Class IIID-0837-2016
Product
Venlafaxine 75 mg Tablet, Compare to Effexor 75 mg Tablet, a) 30-count bottle (NDC 636290-3324-2), b) 100-count bottle (NDC 63629-3324-6), Rx Only, Manufactured by Teva Pharmaceuticals USA, Inc. Packaged by Bryant Ranch.
- Brand name
- Venlafaxine
- Generic name
- Venlafaxine
- Active ingredient
- Venlafaxine Hydrochloride
- Route
- Oral
- NDC
- 63629-3324
- FDA application
- ANDA077653
- Affected lot / code info
- Lot # 94983; Exp 10/17
Why it was recalled
Labeling: Label Mix-Up: Bryant Ranch received Tevas venlafaxine hydrochloride extended-release tablets for repackaging, but labeled it incorrectly as the immediate release formulation.
Recalling firm
- Firm
- Bryant Ranch Prepack Inc.
- Manufacturer
- Bryant Ranch Prepack
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1919 N Victory Pl, Burbank, California 91504-3425
Distribution
- Quantity
- 21 bottles (910 extended release tablets)
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-03-25
- FDA classified
- 2016-05-04
- Posted by FDA
- 2016-05-11
- Terminated
- 2016-08-29
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0837-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.