Drug product
Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 100-count bottle (NDC 10702-0026-01; UPC 3 10702 02601 8) and b) 1000-count bottle (NDC 10702-0026-10; UPC 3 10702 02601 0); Rx only, Mfd. by KVK-TECH, Inc., Newtown, PA
D-1371-2015
Product summary
- Firm
- KVK-Tech, Inc.
- Event
- Event 71726
- Status
- Terminated
- Classification
- Class III
- Quantity
- 9,696 bottles (100-count), 972 bottles (1000-count)
- Official record key
drug-enforcement:D-1371-2015
Official wording
Reason: Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Code information: Lot #: a) 11957A, Exp 04/2017; b) 11956A, Exp 04/2017
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
out-of-specification