Benzhydrocodone and Acetaminophen Tablets, CII, 6.12mg/ 325mg, 100 Tablets, Rx Only, Manufactured...
FDA Recall #D-0224-2021 — Class III — December 18, 2020
Product Description
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
Recalling Firm
KVK-Tech, Inc. — Newtown, PA
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
528 bottles
Distribution
Nationwide
Code Information
Batch# 15892A, Exp, 2021-FEB
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated