FDADecember 18, 2020drug

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

Official recall recorded by the U.S. Food & Drug Administration.

The 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

What to do

FDA enforcement status: Terminated

Brands named

kvk techkvkkvk tech

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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