Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, ...
FDA Recall #D-0066-2021 — Class III — October 26, 2020
Product Description
Olanzapine Orally Disintegrating Tablets, 5 mg, 30 count (3x10 unit dose) blister pack, Rx only, Manufactured by: Jubilant Generics, Ltd., Roorkee, India, Marketed by: Jubilant Cardista Pharmaceuticals, Inc., Salisbury, MD NDC 59746-0306-32
Reason for Recall
Subpotent
Recalling Firm
Jubilant Cadista Pharmaceuticals, Inc. — Salisbury, MD
Classification
Class III — Not likely to cause adverse health consequences.
Product Type
Drugs
Product Quantity
23,616 blister packs
Distribution
Product was distributed nationwide
Code Information
Lot # AE119001A, exp. date 01/2021
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated