OLANZAPINE Recall D-1042-2022
Description: Olanzapine Orally Disintegrating Tablets, USP 10 mg, 30-count box unit dose tablets (3 blister cards each containing 10 tablets), Rx only, MFG: PAR PHARMA, NDC 49884-321-55
OLANZAPINE Recall D-1042-2022 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-1042-2022 |
| Event ID | 89646 |
| Brand | OLANZAPINE |
| Generic Name | OLANZAPINE |
| Manufacturer | OLANZAPINE |
| Original Package? | 1 |
| Active Substance | OLANZAPINE |
| Drug Route | ORAL |
| Distribution | USA nationwide. |
| Quantity | 30 cartons/3 blister packs per carton |
| Recall Reason | cGMP deviations: Temperature abuse |
| Drug Classification | Class II |
| Drug Code Info | 20220615 |
| Product NDC | 49884-320 49884-321 49884-322 |
| Product NUI | N0000175430 |
| Drug UPC | 0349884320553 |
| Pharma Class (EPC) | Atypical Antipsychotic [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 | N7U69T4SZR |
| Drug Application Number | ANDA078109 |
| Structured Product Labeling (SPL ID) | a9cfe55f-7f27-44ec-b51c-ceb546619ff3 |
| Structured Product Labeling (SPL Set ID) | d974d2a4-fc65-42ff-8138-cfcfd7381534 |
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