PREDNISOLONE ACETATE Recall D-1105-2022
Description: Prednisolone Acetate Ophthalmic Suspension, USP 1%, 5 mL bottle, Rx only, MFG: Sandoz Pharma, NDC 61314-637-05
PREDNISOLONE ACETATE Recall D-1105-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1105-2022 |
| Event ID | 89646 |
| Brand | PREDNISOLONE ACETATE |
| Generic Name | PREDNISOLONE ACETATE |
| Manufacturer | PREDNISOLONE ACETATE |
| Original Package? | 1 |
| Active Substance | PREDNISOLONE ACETATE |
| Drug Route | OPHTHALMIC |
| Distribution | USA nationwide. |
| Quantity | 50 bottles |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 61314-637 |
| Drug UPC | 0361314637055 |
| 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 | 8B2807733D |
| Drug Application Number | NDA017469 |
| Structured Product Labeling (SPL ID) | 09d17d81-3127-46b9-8553-ffc22e9434a8 |
| Structured Product Labeling (SPL Set ID) | 05d205c7-8f51-46b9-a6c5-4199bc432b26 |
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