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Recall Observatory FDA recall evidence

Drug product

Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195

D-0027-2015

October 03, 2014

Class II

Product summary

Firm
Sagent Pharmaceuticals Inc
Event
Event 69485
Status
Terminated
Classification
Class II
Quantity
69,050 vials
Official record key
drug-enforcement:D-0027-2015

Official wording

Reason: Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.

Code information: Lot MP5021, Exp. 04/16; Lots MP5024, MP5025, Exp. 05/16

Distribution pattern: Nationwide and Puerto Rico

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    labeling the product with the incorrect