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Recall Observatory FDA recall evidence

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.

D-0205-2017

June 13, 2016

Class III

Product summary

Firm
Jubilant Cadista Pharmaceuticals, Inc.
Event
Event 75954
Status
Terminated
Classification
Class III
Quantity
1512 bottles
Official record key
drug-enforcement:D-0205-2017

Official wording

Reason: 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.

Code information: Lot #: 16P0176, Exp 02/2018 but labeled incorrectly as 02/0218.

Distribution pattern: Nationwide and Puerto Rico.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Incorrect or Missing