# FDA recall D-302-2013

> **Hi-Tech Pharmacal Co., Inc.** · Class III · drug recall initiated 2013-03-11.

## Product

Acetic Acid Otic Solution, USP, 15 mL bottle, Rx Only, Hi-Tech Pharmacal Co., Inc., Amityville, N.Y. 11701, NDC 50383-889-15, UPC 3 50383-889-15 1.

## Reason for recall

Subpotent Drug: The product/lot is out-of-specification (OOS) for the assay of acetic acid at the 18-month test station.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-302-2013
- **Recalling firm:** Hi-Tech Pharmacal Co., Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-03-11
- **Report date:** 2013-05-08
- **Termination date:** 2016-05-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Amityville, NY, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-302-2013

## Citation

> AI Analytics. FDA recall D-302-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-302-2013. Source: US FDA. Licensed CC0.

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