Why it was recalled
Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
Product description
Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195
Lot numbers, UPCs & expiration codes
Lot MP5021, Exp. 04/16; Lots MP5024, MP5025, Exp. 05/16
Where it was sold
Nationwide 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-0027-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 3, 2014
- FDA report date
- Oct 22, 2014
- Quantity
- 69,050 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sagent Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0027-2015, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 69485
- Address
- 1901 N Roselle Rd Ste 700
- Code information
- Lot MP5021, Exp. 04/16; Lots MP5024, MP5025, Exp. 05/16
- Postal code
- 60195-3194
- Report date
- Oct 22, 2014
- Product type
- Drugs
- Recall number
- D-0027-2015
- Classification
- Class II
- Recalling firm
- Sagent Pharmaceuticals Inc
- Product quantity
- 69,050 vials
- Termination date
- Feb 23, 2016
- Reason for recall
- Incorrect or Missing Lot and/or Exp Date: Ketorolac Tromethamine Injection, is being recalled as a result of labeling the product with the incorrect expiration date.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Ketorolac Tromethamine INJECTION, USP, 30 mg per mL, a) 1 mL vial (NDC 25021-701-01) b) 2 mL vial (NDC 25021-701-02), Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195
- Distribution pattern
- Nationwide and Puerto Rico
- Recall initiation date
- Oct 3, 2014
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Oct 16, 2014