Class III
Terminated
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
- Company
- Kvk Tech, Inc.
- Recall Initiated
- July 14, 2015
- Posted
- September 2, 2015
- Recall Number
- D-1371-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9,696 bottles (100-count), 972 bottles (1000-count)
- Firm Location
- Newtown, PA, United States
Reason for Recall
Failed Impurities/Degradation Specifications: out-of-specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Distribution
Nationwide
Lot / Code Info
Lot #: a) 11957A, Exp 04/2017; b) 11956A, Exp 04/2017
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