Why it was recalled
Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.
Product description
Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14.
Lot numbers, UPCs & expiration codes
Lot #: 16P0176, Exp 02/2018 but labeled incorrectly as 02/0218.
Where it was sold
Nationwide and 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-0205-2017
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jun 13, 2016
- FDA report date
- Dec 21, 2016
- Quantity
- 1512 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0205-2017, exactly as published.
Show all FDA fields
- City
- Salisbury
- State
- MD
- Status
- Terminated
- Country
- United States
- Event ID
- 75954
- Address
- 207 Kiley Dr
- Code information
- Lot #: 16P0176, Exp 02/2018 but labeled incorrectly as 02/0218.
- Postal code
- 21801-2249
- Report date
- Dec 21, 2016
- Product type
- Drugs
- Recall number
- D-0205-2017
- Classification
- Class III
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Product quantity
- 1512 bottles
- Termination date
- Jul 12, 2017
- Reason for recall
- Labeling: Incorrect or Missing Lot and/or Exp Date: incorrect expiration date of 02/0218 is printed on the container label instead of the correct expiration date of 02/2018.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14.
- Distribution pattern
- Nationwide and Puerto Rico.
- Recall initiation date
- Jun 13, 2016
- Initial firm notification
- Center classification date
- Dec 15, 2016