Recall: D-1274-2019
Class II - Potentially Harmful
Class IIClassification
2019-04-30Initiated
TerminatedStatus
Sagent Pharmaceuticals IncFirm
Product
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
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
Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.