# FDA recall D-0712-2018

> **Lyne Laboratories, Inc.** · Class II · drug recall initiated 2018-04-13.

## Product

Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-329-20, UPC 364980329200

## Reason for recall

Subpotent Drug

## Distribution

to be entered

## Key facts

- **Recall number:** D-0712-2018
- **Recalling firm:** Lyne Laboratories, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2018-04-13
- **Report date:** 2018-05-02
- **Termination date:** 2019-05-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Brockton, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0712-2018

## Citation

> AI Analytics. FDA recall D-0712-2018. Retrieved 2026-05-26 from https://api.ai-analytics.org/recall/D-0712-2018. Source: US FDA. Licensed CC0.

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