ATROPINE SULFATE Recall D-1035-2022
Description: Isopto Atropine (atropine sulfate ophthalmic solution) 1%, 5mL bottle, MFG: Alcon Surgical, NDC 0065-0303-55
ATROPINE SULFATE Recall D-1035-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1035-2022 |
| Event ID | 89646 |
| Brand | ISOPTO ATROPINE |
| Generic Name | ATROPINE SULFATE |
| Manufacturer | ATROPINE SULFATE |
| Original Package? | 1 |
| Active Substance | ATROPINE SULFATE |
| Drug Route | OPHTHALMIC |
| Distribution | USA nationwide. |
| Quantity | 13 bottles |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0065-0303 |
| 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 | 03J5ZE7KA5 |
| Drug Application Number | NDA208151 |
| Structured Product Labeling (SPL ID) | a834cece-0e6c-4fc4-af6d-4aa8827d5cc1 |
| Structured Product Labeling (SPL Set ID) | 20491566-e6eb-8d4a-3083-77ea429f7bc4 |
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