Product Safety Recalls

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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

StatusOngoing
Mandated?Voluntary: Firm initiated
Recall NumberD-1042-2022
Event ID89646
BrandOLANZAPINE
Generic NameOLANZAPINE
ManufacturerOLANZAPINE
Original Package?1
Active SubstanceOLANZAPINE
Drug RouteORAL
DistributionUSA nationwide.
Quantity30 cartons/3 blister packs per carton
Recall ReasoncGMP deviations: Temperature abuse
Drug ClassificationClass II
Drug Code Info20220615
Product NDC49884-320 49884-321 49884-322
Product NUIN0000175430
Drug UPC0349884320553
Pharma Class (EPC)Atypical Antipsychotic [EPC]
Recall Initiation Date20220413
Report Date20220615
Classification Date20220609
Address9954 Maryland DriveDeep Run Iii Ste. 4000
Richmond, VA 23233
United States
Recalling FirmMckesson Medical-Surgical Inc. Corporate Office
Initial Notification Letter
Unique Ingredient IdentifierN7U69T4SZR
Drug Application NumberANDA078109
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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