Why it was recalled
Subpotent; 18 month time point
Product description
Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11.
Lot numbers, UPCs & expiration codes
Lot Number: 6004137, Expiration date: 06/2014
Where it was sold
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-1148-2014
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 22, 2014
- FDA report date
- Mar 12, 2014
- Quantity
- 161,650 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-1148-2014, exactly as published.
Show all FDA fields
- City
- Grand Island
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 67330
- Address
- 3159 Staley Rd
- Code information
- Lot Number: 6004137, Expiration date: 06/2014
- Postal code
- 14072-2028
- Report date
- Mar 12, 2014
- Product type
- Drugs
- Recall number
- D-1148-2014
- Classification
- Class II
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 161,650 vials
- Termination date
- May 24, 2016
- Reason for recall
- Subpotent; 18 month time point
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11, 25 vials in tray, each boxed vial individually labeled as: Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For IV or SC use, Multi-Dose Vial, Rx only, NDC 63323-540-11.
- Distribution pattern
- Nationwide
- Recall initiation date
- Jan 22, 2014
- Initial firm notification
- Letter
- Center classification date
- Mar 5, 2014