KVK-Tech, Inc. recalls Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured for: KVK-Tech, Inc., N
Recalled January 20, 2021 · FDA recall D-0224-2021 · KVK-Tech
Hazard
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A · FDA Class III
Units
528 bottles
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications; out of specification results obtained for N-Oxide impurity during the 12-month long term stability testing for Batch# 15892A
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
Manufacturer(s)
KVK-Tech, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →