D-1274-2019 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- May 15, 2019
- Initiation Date
- April 30, 2019
- Termination Date
- September 28, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 75,825 vials
Product Description
Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), 2 mL Vials, Rx only, Mfd. for Sagent Pharmaceuticals, Schaumburg, IL 60195, NDC: 25021-701-02
Reason for Recall
Lack of Sterility Assurance: Microbial growth detected during a routine simulation of the manufacturing process, which represents the potential introduction of microorganisms into the products.
Distribution Pattern
Nationwide USA and Puerto Rico
Code Information
Lot #: M813513, Exp. Feb 2020