# FDA recall D-389-2014

> **Hi-Tech Pharmacal Co., Inc.** · Class III · drug recall initiated 2013-10-28.

## Product

Acyclovir Oral Suspension, USP 200 mg/5 mL, Net Wt. 16 fl oz (473 mL), Rx only, Hi-Tech Pharmacal Co, Inc. Amityville, NY 11701.  NDC 50383-810-16.

## Reason for recall

Failed Stability Specification; product viscosity and or pH are below specification.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-389-2014
- **Recalling firm:** Hi-Tech Pharmacal Co., Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-10-28
- **Report date:** 2014-01-01
- **Termination date:** 2016-05-16

- **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-389-2014

## Citation

> AI Analytics. FDA recall D-389-2014. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-389-2014. Source: US FDA. Licensed CC0.

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