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
Product summary
- 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
labeling the product with the incorrect