Recalls / Class II
Class IID-0027-2015
Product
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
- 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 MP5021, Exp. 04/16; Lots MP5024, MP5025, Exp. 05/16
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.
Recalling firm
- Firm
- Sagent Pharmaceuticals Inc
- Manufacturer
- Sagent Pharmaceuticals
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 1901 N Roselle Rd Ste 700, N/A, Schaumburg, Illinois 60195-3194
Distribution
- Quantity
- 69,050 vials
- Distribution pattern
- Nationwide and Puerto Rico
Timeline
- Recall initiated
- 2014-10-03
- FDA classified
- 2014-10-16
- Posted by FDA
- 2014-10-22
- Terminated
- 2016-02-23
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0027-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.