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
Reported: October 22, 2014 Initiated: October 3, 2014 #D-0027-2015
Product Description
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.
Details
- Recalling Firm
- Sagent Pharmaceuticals Inc
- Units Affected
- 69,050 vials
- Distribution
- Nationwide and Puerto Rico
- Location
- Schaumburg, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sagent Pharmaceuticals Inc. Units affected: 69,050 vials.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 22, 2014. Severity: Moderate. Recall number: D-0027-2015.
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