Recalls / Class II
Class IID-0435-2023
Product
Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-404-01
- Brand name
- Heparin Sodium
- Generic name
- Heparin Sodium
- Active ingredient
- Heparin Sodium
- Route
- Intravenous, Subcutaneous
- NDC
- 25021-404
- FDA application
- ANDA090809
- Affected lot / code info
- Lot#: WP201, Exp 2/2024
Why it was recalled
Labeling: Not elsewhere classified
Recalling firm
- Firm
- Sagent Pharmaceuticals Inc
- Manufacturer
- Sagent Pharmaceuticals
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1901 N Roselle Rd Ste 450, Schaumburg, Illinois 60195-3194
Distribution
- Quantity
- 28,875 vials
- Distribution pattern
- USA Nationwide
Timeline
- Recall initiated
- 2023-02-28
- FDA classified
- 2023-03-06
- Posted by FDA
- 2023-03-15
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0435-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.