# FDA recall D-0133-2020

> **Unipharma, Llc.** · Class II · drug recall initiated 2019-09-23.

## Product

DrKids Himasal Natural Nasal Saline Solution, packaged in Pre-measured Singe-Use Vials  a)  0.5 mL Each (20 count) UPC 37030244608; b) 1.5 mL Each (20 count) UPC 370302446098, Manufactured in USA by: UNIPHARMA, LLC Tamarac, FL 33321

## Reason for recall

CGMP Deviations: Recall as a precautionary measure due to potential risk of product contamination with the bacteria B. cepacia.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-0133-2020
- **Recalling firm:** Unipharma, Llc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-09-23
- **Report date:** 2019-10-16
- **Termination date:** 2021-03-23

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Tamarac, FL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0133-2020

## Citation

> AI Analytics. FDA recall D-0133-2020. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0133-2020. Source: US FDA. Licensed CC0.

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