# FDA recall D-0386-2021

> **KVK-Tech, Inc.** · Class III · drug recall initiated 2021-04-27.

## Product

Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech, Inc., Newtown, PA, 18940  NDC 10702-055-03

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0386-2021
- **Recalling firm:** KVK-Tech, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-04-27
- **Report date:** 2021-05-26
- **Termination date:** 2022-10-05

- **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-0386-2021

## Citation

> AI Analytics. FDA recall D-0386-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0386-2021. Source: US FDA. Licensed CC0.

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