D-1162-2017 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 20, 2017
- Initiation Date
- September 5, 2017
- Termination Date
- December 4, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35 bottles
Product Description
Phentermine, USP Capsules, 15 mg, 30 count bottles, Rx only, Packaged By: Aidarex Pharmaceuticals, Corona, CA, MFG: KVK-TECH INC. Newtown. PA --- 33261-0361-30
Reason for Recall
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Distribution Pattern
Distributed to the state of CA and NV.
Code Information
Batch 47262-2, 47262-3, exp 8/31/2017; 47262-4, exp 12/30/17, 47262-5, 47262-6, 47262-7, exp 12/31/17