Drug product
TEMAZEPAM CAPSULES USP, 7.5 mg, 100 count bottles, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-5891-21
D-0326-2017
Product summary
- Event
- Event 76087
- Status
- Terminated
- Classification
- Class III
- Quantity
- 1200 bottles
- Official record key
drug-enforcement:D-0326-2017
Official wording
Reason: Failed Stability Specifications
Code information: T248H15A, Exp. 08/17
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications