Why it was recalled
Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
Product description
MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
Lot numbers, UPCs & expiration codes
Lot # 17P0078, exp. date 12/2018
Where it was sold
Product was distributed throughout the United States.
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-1205-2018
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Aug 27, 2018
- FDA report date
- Sep 26, 2018
- Quantity
- 89,722 blister pack
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-1205-2018, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 80951
- Address
- 207 Kiley Dr
- Code information
- Lot # 17P0078, exp. date 12/2018
- Postal code
- 21801-2249
- Report date
- Sep 26, 2018
- Product type
- Drugs
- Recall number
- D-1205-2018
- Classification
- Class III
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 89,722 blister pack
- Termination date
- Oct 8, 2019
- Reason for recall
- Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03
- Distribution pattern
- Product was distributed throughout the United States.
- Recall initiation date
- Aug 27, 2018
- Initial firm notification
- Letter
- Center classification date
- Sep 21, 2018