D-1083-2017 Class III Terminated
FDA drug recall D-1083-2017 was initiated by KVK-Tech, Inc. on August 3, 2017 and is designated Class III. Reason for recall: Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test. The recall status is terminated (terminated December 4, 2018). Affected quantity: 35,267 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- August 23, 2017
- Initiation Date
- August 3, 2017
- Termination Date
- December 4, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,267 bottles
Product Description
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
Reason for Recall
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Distribution Pattern
Nationwide in the United States
Code Information
Lot # a):12322A, 12323B, 12324A, Exp. Sep 2017; 12455A, Exp. Dec 2017; b) 12323A, Exp. Sep 2017; 12456A, Exp. Dec 2017