Drug recall D-0027-2015

Class II Terminated reported Oct 22, 2014

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

Reason for recall

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.

Lots and codes

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

Recall details

Recalling firm
Sagent Pharmaceuticals Inc, Schaumburg, IL
Quantity
69,050 vials
Distribution
Nationwide and Puerto Rico
Type
Voluntary: Firm initiated
Recall initiated
October 3, 2014
Terminated
February 23, 2016

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