FDA recall D-0066-2021

Jubilant Cadista Pharmaceuticals, Inc. · Class III · drug

Product

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

Product was distributed nationwide

Key facts

Status: Terminated
Initiation date: 2020-10-26
Report date: 2020-11-11
Termination date: 2021-08-11
Voluntary/Mandated: Voluntary: Firm initiated
Location: Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0066-2021