D-0027-2015 Class II Terminated
FDA drug recall D-0027-2015 was initiated by Sagent Pharmaceuticals Inc on Oct 3, 2014 and is designated Class II. 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. The recall status is terminated (terminated Feb 23, 2016). Affected quantity: 69,050 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 22, 2014
- Initiation Date
- Oct 3, 2014
- Termination Date
- Feb 23, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 69,050 vials
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot MP5021, Exp. 04/16; Lots MP5024, MP5025, Exp. 05/16
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0027-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026