Why it was recalled
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Product description
Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01
Lot numbers, UPCs & expiration codes
Lot #: 6110593, Exp 11/2016
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-1327-2015
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 28, 2015
- FDA report date
- Aug 19, 2015
- Quantity
- 93,000 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Fresenius Kabi USA, LLC
Original FDA data
Every field from FDA enforcement report D-1327-2015, exactly as published.
Show all FDA fields
- City
- Lake Zurich
- State
- IL
- Status
- Terminated
- Country
- United States
- Event ID
- 71827
- Address
- 3 Corporate Dr
- Code information
- Lot #: 6110593, Exp 11/2016
- Postal code
- 60047-8930
- Report date
- Aug 19, 2015
- Product type
- Drugs
- Recall number
- D-1327-2015
- Classification
- Class III
- Recalling firm
- Fresenius Kabi USA, LLC
- Product quantity
- 93,000 vials
- Termination date
- Mar 8, 2016
- Reason for recall
- Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL; single dose vial. Manufactured by Fresenius Kabi USA 2020 N Ruby Street, Melrose Park, IL 60160-1112 for Fresenius Kabi USA, 3 Corporate Dr Lake Zurich, IL 60047-8930. NDC 63323-614-01
- Distribution pattern
- Nationwide
- Recall initiation date
- Jul 28, 2015
- Initial firm notification
- Letter
- Center classification date
- Aug 12, 2015