FDAClass IIOctober 22, 2014

Ketorolac Tromethamine INJECTION recall: Labeling Error

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…

Why was Ketorolac Tromethamine INJECTION recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

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…
Recalling firm
Sagent Pharmaceuticals Inc
Quantity
69,050 vials
Distribution
Nationwide and Puerto Rico
Recall date
October 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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