CARBACHOL Recall D-1036-2022
Description: MIOSTAT (Carbachol Intraocular Solution, USP) 0.01%, 1.5 mL, Rx only, MFG: Alcon Surgical Inc., NDC 0065-0023-15
CARBACHOL Recall D-1036-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1036-2022 |
| Event ID | 89646 |
| Brand | MIOSTAT |
| Generic Name | CARBACHOL |
| Manufacturer | CARBACHOL |
| Original Package? | 1 |
| Active Substance | CARBACHOL |
| Drug Route | OPHTHALMIC |
| Distribution | USA nationwide. |
| Quantity | 8 boxes/12 vials each |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0065-0023 |
| Recall Initiation Date | 20220413 |
| Report Date | 20220615 |
| Classification Date | 20220609 |
| Address | 9954 Maryland DriveDeep Run Iii Ste. 4000 Richmond, VA 23233 United States |
| Recalling Firm | Mckesson Medical-Surgical Inc. Corporate Office |
| Initial Notification | Letter |
| Unique Ingredient Identifier | 8Y164V895Y |
| Drug Application Number | NDA016968 |
| Structured Product Labeling (SPL ID) | dc823099-2746-41e7-8da8-d56fc6eafe4d |
| Structured Product Labeling (SPL Set ID) | f28d7a56-e079-4a8b-ad81-9a97c780de67 |
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