# FDA recall D-1367-2020

> **Rising Pharmaceuticals, Inc.** · Class III · drug recall initiated 2019-11-15.

## Product

Timolol Maleate USP, 0.5%, 5 mL,  Sterile Opthalmic Solution,  Rx Only, For Topical Application in the Eye, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07663, Manufactured by: FDC Limited B-8, MIDC Industrial Area, Waluj, Aurangbad - 431 136 Marahastra, India, NDC 64980-514-05

## Reason for recall

Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-1367-2020
- **Recalling firm:** Rising Pharmaceuticals, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-11-15
- **Report date:** 2020-07-01
- **Termination date:** 2022-08-22

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saddle Brook, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1367-2020

## Citation

> AI Analytics. FDA recall D-1367-2020. Retrieved 2026-06-04 from https://api.ai-analytics.org/recall/D-1367-2020. Source: US FDA. Licensed CC0.

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