PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: June 15, 2022 Initiated: April 13, 2022 #D-1042-2022

Product 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

Reason for Recall

cGMP deviations: Temperature abuse

Details

Units Affected
30 cartons/3 blister packs per carton
Distribution
USA nationwide.
Location
Richmond, VA

Frequently Asked Questions

What product was recalled?
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. Recalled by Mckesson Medical-Surgical Inc. Corporate Office. Units affected: 30 cartons/3 blister packs per carton.
Why was this product recalled?
cGMP deviations: Temperature abuse
Which agency issued this recall?
This recall was issued by the FDA Drug on June 15, 2022. Severity: Moderate. Recall number: D-1042-2022.