# FDA recall D-1883-2019

> **Akorn, Inc.** · Class II · drug recall initiated 2019-09-20.

## Product

Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest, IL 60045; NDC 17478-201-15.

## Reason for recall

Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-1883-2019
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-09-20
- **Report date:** 2019-10-09
- **Termination date:** 2022-08-01

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1883-2019

## Citation

> AI Analytics. FDA recall D-1883-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-1883-2019. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*