Recalls / Class III
Class IIID-0066-2021
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
- Affected lot / code info
- Lot # AE119001A, exp. date 01/2021
Why it was recalled
Subpotent
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, N/A, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 23,616 blister packs
- Distribution pattern
- Product was distributed nationwide
Timeline
- Recall initiated
- 2020-10-26
- FDA classified
- 2020-11-05
- Posted by FDA
- 2020-11-11
- Terminated
- 2021-08-11
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0066-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.