HYDROCORTISONE Recall D-1045-2022
Description: Hydrocortisone Ointment USP, 2.5%, NET WT 28.35 g (1 oz) tube, Rx only, MFG: Sandoz Pharma, NDC 0168-0146-30
HYDROCORTISONE Recall D-1045-2022 Information
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1045-2022 |
Event ID | 89646 |
Brand | HYDROCORTISONE |
Generic Name | HYDROCORTISONE |
Manufacturer | HYDROCORTISONE |
Original Package? | 1 |
Active Substance | HYDROCORTISONE |
Drug Route | TOPICAL |
Distribution | USA nationwide. |
Quantity | 1 tube |
Recall Reason | cGMP deviations: Temperature abuse |
Drug Classification | Class II |
Drug Code Info | 20220615 |
Product NDC | 0168-0080 0168-0146 |
Product NUI | N0000175576 N0000175450 |
Drug UPC | 0301680146300 0301680080314 |
Pharma Class (EPC) | Corticosteroid [EPC] |
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 | WI4X0X7BPJ |
Drug Application Number | ANDA089414 |
Structured Product Labeling (SPL ID) | b70bed43-6eed-4355-90b5-9d0819c13ebd |
Structured Product Labeling (SPL Set ID) | bcd103f3-3dc8-4394-b8fd-8f8ddb721f77 |
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