# FDA recall D-0374-2024

> **Thea Pharma, Inc.** · Class II · drug recall initiated 2024-03-05.

## Product

Betimol (timolol ophthalmic solution) 0.5%,  15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15

## Reason for recall

Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.

## Distribution

Product was distributed nationwide within the United States

## Key facts

- **Recall number:** D-0374-2024
- **Recalling firm:** Thea Pharma, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2024-03-05
- **Report date:** 2024-03-20
- **Termination date:** 2025-06-30

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0374-2024

## Citation

> AI Analytics. FDA recall D-0374-2024. Retrieved 2026-06-12 from https://api.ai-analytics.org/recall/D-0374-2024. Source: US FDA. Licensed CC0.

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