D-0066-2021 Class III Terminated
FDA drug recall D-0066-2021 was initiated by Jubilant Cadista Pharmaceuticals, Inc. on October 26, 2020 and is designated Class III. Reason for recall: Subpotent The recall status is terminated (terminated August 11, 2021). Affected quantity: 23,616 blister packs.
Recall Details
- Product Type
- Drugs
- Report Date
- November 11, 2020
- Initiation Date
- October 26, 2020
- Termination Date
- August 11, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 23,616 blister packs
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
Distribution Pattern
Product was distributed nationwide
Code Information
Lot # AE119001A, exp. date 01/2021