FDA recall D-0205-2017

Jubilant Cadista Pharmaceuticals, Inc. · Class III · drug

Product

Methylprednisolone Tablets, USP, 16 mg, 50-count bottles, Rx only, Manufactured by Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-003-14.

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.

Distribution

Nationwide and Puerto Rico.

Key facts

Status
Terminated
Initiation date
2016-06-13
Report date
2016-12-21
Termination date
2017-07-12
Voluntary/Mandated
Voluntary: Firm initiated
Location
Salisbury, MD, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0205-2017