July 2015 FDA Recall Hydralazine Hydrochloride by Fresenius Kabi Usa, Llc
D-1327-2015 - Incorrect Expiration Date
This Class III drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on July 28, 2015 for the product Hydralazine Hydrochloride. The FDA reported the reason for recall as incorrect expiration date. The product was distributed Nationwide and the recall is currently terminated.
Recall Number: D-1327-2015
Incorrect Expiration Date: The "11/06" expiration date printed on the tray (secondary packaging) is incorrect (it should be 11/2016)
07-28-2015
08-19-2015
93,000 vials
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fresenius Kabi USA, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide
03-08-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# : 6110593, Exp 11/2016
