# FDA recall D-1498-2016

> **Allergy Laboratories, Inc.** · Class II · drug recall initiated 2016-08-10.

## Product

Ephedrine Sulfate Injection, USP, 50 mg/mL, Single Dose Vial, packaged in a) 1 mL fill in a 2 mL Vial (NDC: 69053-008-01); and b) 25 x 2 mL Vials (NDC 69053-008-02), Rx only, Manufactured for: Andersen Pharmaceutical, White Plains, NY  10605.

## Reason for recall

Lack of Assurance of Sterility: An FDA inspection at the facility raised concerns that product sterility was potentially impacted.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1498-2016
- **Recalling firm:** Allergy Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-08-10
- **Report date:** 2016-09-14
- **Termination date:** 2017-03-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Oklahoma City, OK, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1498-2016

## Citation

> AI Analytics. FDA recall D-1498-2016. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-1498-2016. Source: US FDA. Licensed CC0.

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