Why it was recalled
Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
Product description
Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-001-03
Lot numbers, UPCs & expiration codes
Lot #: 20K0043P, 20K0044P, 20K0042P, Exp 08/2022; 20L0026P, 20L0027P, 20L0028P, 20L0029P, 20L0030P, Exp 09/2022
Where it was sold
USA nationwide, including Puerto Rico.
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-0298-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 19, 2021
- FDA report date
- Mar 10, 2021
- Quantity
- 635,400 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0298-2021, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 87342
- Address
- 207 Kiley Dr
- Code information
- Lot #: 20K0043P, 20K0044P, 20K0042P, Exp 08/2022; 20L0026P, 20L0027P, 20L0028P, 20L0029P, 20L0030P, Exp 09/2022
- Postal code
- 21801-2249
- Report date
- Mar 10, 2021
- Product type
- Drugs
- Recall number
- D-0298-2021
- Classification
- Class III
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 635,400 cartons
- Termination date
- Nov 15, 2022
- Reason for recall
- Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methylprednisolone Tablets USP, 4 MG, packaged in a 21-count blister pack, Rx only, Jubilant Cadista Pharmaceuticals, Inc., Salisbury, MD 21801, NDC 59746-001-03
- Distribution pattern
- USA nationwide, including Puerto Rico.
- Recall initiation date
- Feb 19, 2021
- Initial firm notification
- Letter
- Center classification date
- Mar 4, 2021