# FDA recall D-0224-2021

> **KVK-Tech, Inc.** · Class III · drug recall initiated 2020-12-18.

## 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

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0224-2021
- **Recalling firm:** KVK-Tech, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-12-18
- **Report date:** 2021-01-20
- **Termination date:** 2021-03-19

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Newtown, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0224-2021

## Citation

> AI Analytics. FDA recall D-0224-2021. Retrieved 2026-09-08 from https://api.ai-analytics.org/recall/D-0224-2021. Source: US FDA. Licensed CC0.

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