Why it was recalled
Subpotent
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
Lot numbers, UPCs & expiration codes
Lot # AE119001A, exp. date 01/2021
Where it was sold
Product was distributed nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0066-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Oct 26, 2020
- FDA report date
- Nov 11, 2020
- Quantity
- 23,616 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0066-2021, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 86658
- Address
- 207 Kiley Dr
- Code information
- Lot # AE119001A, exp. date 01/2021
- Postal code
- 21801-2249
- Report date
- Nov 11, 2020
- Product type
- Drugs
- Recall number
- D-0066-2021
- Classification
- Class III
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 23,616 blister packs
- Termination date
- Aug 11, 2021
- Reason for recall
- Subpotent
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Product was distributed nationwide
- Recall initiation date
- Oct 26, 2020
- Initial firm notification
- Letter
- Center classification date
- Nov 5, 2020