Product Safety Recalls

Product Recall Tracker

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

Mandated?Voluntary: Firm initiated
Recall NumberD-1042-2022
Event ID89646
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
Similar To

© 2021 Recall.Report / Contact / Privacy Policy

This site's data is aggregated programmatically and provided "as is" without any representations or warranties, express or implied. is not affiliated with the Consumer Product Safety Commision, FDA, or US government in any way.