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.
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
Lot numbers, UPCs & expiration codes
Lot #: M813513, Exp. Feb 2020
Where it was sold
Nationwide USA and Puerto Rico
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1274-2019
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 30, 2019
- FDA report date
- May 15, 2019
- Quantity
- 75,825 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sagent Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-1274-2019, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 82741
- Address
- 1901 N Roselle Rd Ste 700
- Code information
- Lot #: M813513, Exp. Feb 2020
- Postal code
- 60195-3194
- Report date
- May 15, 2019
- Product type
- Drugs
- Recall number
- D-1274-2019
- Classification
- Class II
- Recalling firm
- Sagent Pharmaceuticals Inc
- Product quantity
- 75,825 vials
- Termination date
- Sep 28, 2020
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide USA and Puerto Rico
- Recall initiation date
- Apr 30, 2019
- Initial firm notification
- Letter
- Center classification date
- May 9, 2019