Drug product
Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30
D-1162-2017
Product summary
- Event
- Event 78067
- Status
- Terminated
- Classification
- Class III
- Quantity
- 35 bottles
- Official record key
drug-enforcement:D-1162-2017
Official wording
Reason: Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Code information: Batch 47262-2, 47262-3, exp 8/31/2017; 47262-4, exp 12/30/17, 47262-5, 47262-6, 47262-7, exp 12/31/17
Distribution pattern: Distributed to the state of CA and NV.
Derived failure modes
-
Potency or specification failure
out-of-specification