Drug recall D-1371-2015

Class III Terminated reported Sep 2, 2015

Product

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

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

Lots and codes

Lot #: a) 11957A, Exp 04/2017; b) 11956A, Exp 04/2017

Recall details

Recalling firm
KVK-Tech, Inc., Newtown, PA
Quantity
9,696 bottles (100-count), 972 bottles (1000-count)
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
July 14, 2015
Terminated
January 13, 2017