ONDANSETRON HYDROCHLORIDE Recall D-1103-2022
Description: Ondansetron HCL, Tab 8 mg filmcoated, 30-count bottle, Rx only, MFG: Sandoz Pharma, NDC 65862-188-30
ONDANSETRON HYDROCHLORIDE Recall D-1103-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1103-2022 |
| Event ID | 89646 |
| Brand | ONDANSETRON HYDROCHLORIDE |
| Generic Name | ONDANSETRON HYDROCHLORIDE |
| Manufacturer | ONDANSETRON HYDROCHLORIDE |
| Original Package? | 1 |
| Active Substance | ONDANSETRON HYDROCHLORIDE |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 2 bottles/500 tablets each |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 65862-187 65862-188 65862-189 |
| 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 | NMH84OZK2B |
| Drug Application Number | ANDA078539 |
| Structured Product Labeling (SPL ID) | 16e894c6-554d-4cff-b66f-a612c5cfa8a3 |
| Structured Product Labeling (SPL Set ID) | 57578387-1918-4e56-a564-f14fb22340bf |
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