# FDA recall D-1631-2019

> **Unipharma, Llc.** · Class II · drug recall initiated 2019-07-15.

## Product

CVS Health Children's Allergy Relief Liquid Medication Diphenhydramine HCl 12.5 mg/5 mL Oral Solution, Antihistamine, Mixed Berry Flavor, 20 Single-Use Vials per Carton, 0.17 fl. oz. (5 mL) Each, 3.4 fl. oz. (100 mL) Total Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895, NDC 69842-261-01 UPC 050428597156

## Reason for recall

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

## Distribution

Nationwide in the US.

## Key facts

- **Recall number:** D-1631-2019
- **Recalling firm:** Unipharma, Llc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-07-15
- **Report date:** 2019-08-14
- **Termination date:** 2020-06-05

- **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-1631-2019

## Citation

> AI Analytics. FDA recall D-1631-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1631-2019. Source: US FDA. Licensed CC0.

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