HYDROXYZINE PAMOATE Recall D-1046-2022
Description: HydrOXYzine Pamoate Capsules, USP, 50 mg, 100-count bottle, Rx only, MFG: Sandoz Pharma, NDC 0185-0615-01
HYDROXYZINE PAMOATE Recall D-1046-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1046-2022 |
| Event ID | 89646 |
| Brand | HYDROXYZINE PAMOATE |
| Generic Name | HYDROXYZINE PAMOATE |
| Manufacturer | HYDROXYZINE PAMOATE |
| Original Package? | 1 |
| Active Substance | HYDROXYZINE PAMOATE |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 30 bottles/100 capsules per bottle |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 0185-0615 0185-0674 0185-0613 |
| Drug UPC | 0301850613014 |
| 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 | M20215MUFR |
| Drug Application Number | ANDA086183 |
| Structured Product Labeling (SPL ID) | 65bed804-a514-4e9f-87b3-1dd026778a6c |
| Structured Product Labeling (SPL Set ID) | c38cfd32-2562-4d6c-8a2e-d9984c16d9eb |
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