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Recall Observatory FDA recall evidence

Drug product

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

D-0298-2021

February 19, 2021

Class III

Product summary

Firm
Jubilant Cadista Pharmaceuticals, Inc.
Event
Event 87342
Status
Terminated
Classification
Class III
Quantity
635,400 cartons
Official record key
drug-enforcement:D-0298-2021

Official wording

Reason: Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.

Code information: Lot #: 20K0043P, 20K0044P, 20K0042P, Exp 08/2022; 20L0026P, 20L0027P, 20L0028P, 20L0029P, 20L0030P, Exp 09/2022

Distribution pattern: USA nationwide, including Puerto Rico.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Labeling: Illegible label: Customer complaint received of mis-alignment print of the printed dosing instructions on the blister card.