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
Reported: August 19, 2015 Initiated: July 28, 2015 #D-1327-2015
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
Reason for Recall
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Details
- Recalling Firm
- Fresenius Kabi USA, LLC
- Units Affected
- 93,000 vials
- Distribution
- Nationwide
- Location
- Lake Zurich, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Fresenius Kabi USA, LLC. Units affected: 93,000 vials.
Why was this product recalled? ▼
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 19, 2015. Severity: Low. Recall number: D-1327-2015.
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