# FDA recall D-0532-2020

> **KVK-Tech, Inc.** · Class II · drug recall initiated 2019-11-01.

## Product

Hydrocodone Bitartrate and Homatropine Methlybromide Oral Solution 5 mg/1.5 mg per 5 mL, 473 mL bottles, Rx only, Mfd. by: KVK-Tech, Inc. Newtown PA 18940; NDC 10702-150-16

## Reason for recall

Presence of Foreign Substance: Black particles were found in the lots during retain sample inspection

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0532-2020
- **Recalling firm:** KVK-Tech, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-11-01
- **Report date:** 2019-11-20
- **Termination date:** 2020-04-16

- **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-0532-2020

## Citation

> AI Analytics. FDA recall D-0532-2020. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/D-0532-2020. Source: US FDA. Licensed CC0.

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