Recalls / Class III
Class IIID-0205-2017
Product
Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14.
- Brand name
- Methylprednisolone
- Generic name
- Methylprednisolone
- Active ingredient
- Methylprednisolone
- Route
- Oral
- NDCs
- 59746-001, 59746-002, 59746-003, 59746-015
- FDA application
- ANDA040189
- Affected lot / code info
- Lot #: 16P0176, Exp 02/2018 but labeled incorrectly as 02/0218.
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.
Recalling firm
- Firm
- Jubilant Cadista Pharmaceuticals, Inc.
- Manufacturer
- Jubilant Cadista Pharmaceuticals Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 207 Kiley Dr, Salisbury, Maryland 21801-2249
Distribution
- Quantity
- 1512 bottles
- Distribution pattern
- Nationwide and Puerto Rico.
Timeline
- Recall initiated
- 2016-06-13
- FDA classified
- 2016-12-15
- Posted by FDA
- 2016-12-21
- Terminated
- 2017-07-12
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0205-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.