Drug product
Phentermine HCL Capsules, USP 15 mg, packaged in a) 100-count bottles (NDC 10702-026-01), and b) 1000-count bottles (NDC 10702-026-10), Rx only, mfd. by: KVK-TECH, INC. NEWTOWN, PA 18940
D-1083-2017
Product summary
- Firm
- KVK-Tech, Inc.
- Event
- Event 77878
- Status
- Terminated
- Classification
- Class III
- Quantity
- 35,267 bottles
- Official record key
drug-enforcement:D-1083-2017
Official wording
Reason: Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Code information: Lot # a):12322A, 12323B, 12324A, Exp. Sep 2017; 12455A, Exp. Dec 2017; b) 12323A, Exp. Sep 2017; 12456A, Exp. Dec 2017
Distribution pattern: Nationwide in the United States
Derived failure modes
-
Potency or specification failure
out-of-specification