Class II
Terminated
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
- Company
- Sagent Pharmaceuticals Inc
- Recall Initiated
- April 30, 2019
- Posted
- May 15, 2019
- Recall Number
- D-1274-2019
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 75,825 vials
- Firm Location
- Schaumburg, IL, United States
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
Nationwide USA and Puerto Rico
Lot / Code Info
Lot #: M813513, Exp. Feb 2020
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