Class III
Terminated
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
- Company
- Kvk Tech, Inc.
- Recall Initiated
- August 3, 2017
- Posted
- August 23, 2017
- Recall Number
- D-1083-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 35,267 bottles
- Firm Location
- Newtown, PA, United States
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
Nationwide in the United States
Lot / Code Info
Lot # a):12322A, 12323B, 12324A, Exp. Sep 2017; 12455A, Exp. Dec 2017; b) 12323A, Exp. Sep 2017; 12456A, Exp. Dec 2017
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