Drug recall D-1083-2017
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
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.
Lots and codes
Lot # a):12322A, 12323B, 12324A, Exp. Sep 2017; 12455A, Exp. Dec 2017; b) 12323A, Exp. Sep 2017; 12456A, Exp. Dec 2017
Recall details
- Recalling firm
- KVK-Tech, Inc., Newtown, PA
- Quantity
- 35,267 bottles
- Distribution
- Nationwide in the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- August 3, 2017
- Terminated
- December 4, 2018
Related products
- Phentermine Hydrochloride – drug information
- NDC 10702-027 Phentermine Hydrochloride · Phentermine Hydrochloride 30 mg/1 · KVK-Tech, Inc.
- NDC 10702-028 Phentermine Hydrochloride · Phentermine Hydrochloride 30 mg/1 · KVK-Tech, Inc.
- NDC 10702-026 Phentermine Hydrochloride · Phentermine Hydrochloride 15 mg/1 · KVK-Tech, Inc.