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
Reported: May 15, 2019 Initiated: April 30, 2019 #D-1274-2019
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.
Details
- Recalling Firm
- Sagent Pharmaceuticals Inc
- Units Affected
- 75,825 vials
- Distribution
- Nationwide USA and Puerto Rico
- Location
- Schaumburg, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Sagent Pharmaceuticals Inc. Units affected: 75,825 vials.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 15, 2019. Severity: Moderate. Recall number: D-1274-2019.
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