Recalls / Class III
Class IIID-0326-2017
Product
TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5891-21
- Affected lot / code info
- T248H15A, Exp. 08/17
Why it was recalled
Failed Stability Specifications
Recalling firm
- Firm
- Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 150 Vintage Dr NE, N/A, Huntsville, Alabama 35811-8216
Distribution
- Quantity
- 1200 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-12-22
- FDA classified
- 2017-01-03
- Posted by FDA
- 2017-01-11
- Terminated
- 2017-09-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0326-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.