Recalls / Class II
Class IID-1274-2019
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
- Brand name
- Ketorolac Tromethamine
- Generic name
- Ketorolac Tromethamine
- Active ingredient
- Ketorolac Tromethamine
- Route
- Intramuscular, Intravenous
- NDCs
- 25021-700, 25021-701
- FDA application
- ANDA204216
- Affected lot / code info
- Lot #: M813513, Exp. Feb 2020
Why it was 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.
Recalling firm
- Firm
- Sagent Pharmaceuticals Inc
- Manufacturer
- Sagent Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1901 N Roselle Rd Ste 700, N/A, Schaumburg, Illinois 60195-3194
Distribution
- Quantity
- 75,825 vials
- Distribution pattern
- Nationwide USA and Puerto Rico
Timeline
- Recall initiated
- 2019-04-30
- FDA classified
- 2019-05-09
- Posted by FDA
- 2019-05-15
- Terminated
- 2020-09-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1274-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.