Recalls / Class III
Class IIID-1327-2015
Product
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
- Brand name
- Hydralazine Hydrochloride
- Generic name
- Hydralazine Hydrochloride
- Active ingredient
- Hydralazine Hydrochloride
- Route
- Intramuscular, Intravenous
- NDC
- 63323-614
- FDA application
- ANDA040388
- Affected lot / code info
- Lot #: 6110593, Exp 11/2016
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)
Recalling firm
- Firm
- Fresenius Kabi USA, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3 Corporate Dr, N/A, Lake Zurich, Illinois 60047-8930
Distribution
- Quantity
- 93,000 vials
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2015-07-28
- FDA classified
- 2015-08-12
- Posted by FDA
- 2015-08-19
- Terminated
- 2016-03-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1327-2015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.