# FDA recall D-0678-2017

> **Novartis Pharmaceuticals Corp.** · Class III · drug recall initiated 2017-03-22.

## Product

Isopto Carpine (pilocarpine hydrochloride opthalmic solution) 4%, packaged in 15 mL bottle, Rx only,  Manufactured by: Alcon Laboratories, Inc. Fort Worth Texas 76134 USA   NDC 0998-0206-15

## Reason for recall

Failed Impurities/Degradation Specifications.

## Distribution

nationwide

## Key facts

- **Recall number:** D-0678-2017
- **Recalling firm:** Novartis Pharmaceuticals Corp.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2017-03-22
- **Report date:** 2017-05-03
- **Termination date:** 2020-02-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** East Hanover, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0678-2017

## Citation

> AI Analytics. FDA recall D-0678-2017. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-0678-2017. Source: US FDA. Licensed CC0.

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