TIMOLOL Recall D-0374-2024
Description: Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
TIMOLOL Recall D-0374-2024 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0374-2024 |
| Event ID | 94146 |
| Brand | BETIMOL |
| Generic Name | TIMOLOL |
| Manufacturer | TIMOLOL |
| Original Package? | 1 |
| Active Substance | TIMOLOL |
| Drug Route | OPHTHALMIC |
| Distribution | Product was distributed nationwide within the United States |
| Quantity | 5,476 bottles |
| Recall Reason | Lack of Assurance of Sterility: Out of specification for volume and compromised container closure. |
| Drug Classification | Class II |
| Drug Code Info | 20240320 |
| Product NDC | 82584-001 82584-002 |
| Recall Initiation Date | 20240305 |
| Report Date | 20240320 |
| Classification Date | 20240311 |
| Address | 303 Wyman St Waltham, MA 02451-1208 United States |
| Recalling Firm | Thea Pharma, Inc. |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 817W3C6175 |
| Drug Application Number | NDA020439 |
| Structured Product Labeling (SPL ID) | 049ec4eb-aa64-7d84-e063-6294a90af57b |
| Structured Product Labeling (SPL Set ID) | 3ae775f4-340c-4bf4-aa49-8a31daba0f8b |
| Similar To |