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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