Drug recall D-0224-2021

Class III Terminated reported Jan 20, 2021

Product

Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., Newtown, PA 18940 USA, NDC 10702-344-01

Reason for recall

Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A

Lots and codes

Batch# 15892A, Exp, 2021-FEB

Recall details

Recalling firm
KVK-Tech, Inc., Newtown, PA
Quantity
528 bottles
Distribution
Nationwide
Type
Voluntary: Firm initiated
Recall initiated
December 18, 2020
Terminated
March 19, 2021