KVK-Tech, Inc. is recalling 528 bottles of Benzhydrocodone and Acetaminophen (6.12mg/325mg) tablets, an opioid pain medication. The recall was initiated because routine stability testing found that a specific impurity, N-Oxide, exceeded acceptable safety levels after 12 months. This batch consists of 100-count bottles sold under NDC 10702-344-01.
The presence of impurities above the approved limit can change the chemical profile of the medication, potentially leading to unintended side effects or reduced effectiveness of the treatment.
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Sources: FDA iRES · Raw API Response
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