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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