Ketorolac Tromethamine Injection recall: Sterility Concern
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…
Why was Ketorolac Tromethamine Injection 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: M813513, Exp. Feb 2020
- 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…
- Recalling firm
- Sagent Pharmaceuticals Inc
- Quantity
- 75,825 vials
- Distribution
- Nationwide USA and Puerto Rico
- Recall date
- May 15, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)