Why it was recalled
Labeling: Not elsewhere classified
Product description
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
Lot numbers, UPCs & expiration codes
Lot#: WP201, Exp 2/2024
Where it was sold
USA Nationwide
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-0435-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 28, 2023
- FDA report date
- Mar 15, 2023
- Quantity
- 28,875 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Sagent Pharmaceuticals Inc
Original FDA data
Every field from FDA enforcement report D-0435-2023, exactly as published.
Show all FDA fields
- City
- Schaumburg
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 91789
- Address
- 1901 N Roselle Rd Ste 450
- Code information
- Lot#: WP201, Exp 2/2024
- Postal code
- 60195-3194
- Report date
- Mar 15, 2023
- Product type
- Drugs
- Recall number
- D-0435-2023
- Classification
- Class II
- Recalling firm
- Sagent Pharmaceuticals Inc
- Product quantity
- 28,875 vials
- Termination date
- May 19, 2026
- Reason for recall
- Labeling: Not elsewhere classified
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Feb 28, 2023
- Initial firm notification
- Letter
- Center classification date
- Mar 6, 2023