Multi-event May 2014 FDA Recall Fosphenytoin by Fresenius Kabi Usa, Llc
This Multi-event Class II drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on May 2, 2014 for the product Fosphenytoin. The FDA reported the reason for recall as presence of particular matter. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-1429-2014
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
05-02-2014
07-16-2014
728,880 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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 and Puerto Rico
05-24-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10
Batch or Lot Expiration Information
Lot# 6003854; 04/14 6003855; 04/14 6004011; 05/14 6003961; 05/14 6004091; 06/14 6004092; 06/14 6004553; 08/14 6004554; 08/14 6004588; 09/14 6004589; 09/14 6005201; 12/14 6005202; 12/14 6005293; 12/14 6005294; 12/14 6005545; 02/15 6005546; 02/15 6005831; 03/15 6005832; 03/15 6005973; 04/15 6005974; 04/15 6006035; 05/15 6006036; 05/15 6006037; 05/15 6006174; 05/15 6006175; 05/15 6006176; 06/15 6006449; 07/15 6006450; 07/15 6006451; 07/15 6007168; 11/15
Affected Packages Involved in this Recall
Recall Number: D-1428-2014
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
05-02-2014
07-16-2014
2,070,500 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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 and Puerto Rico
05-24-2016
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02
Batch or Lot Expiration Information
Lot# 6003850; 04/14 6003926; 05/14 6004052; 05/14 6004053; 05/14 6004093; 06/14 6004094; 06/14 6004199; 07/14 6004200; 07/14 6004509; 08/14 6004510; 08/14 6004661; 09/14 6005157; 11/14 6005158; 11/14 6005197; 11/14 6005198; 11/14 6005446; 01/15 6005447; 01/15 6005702; 03/15 6005703; 03/15 6005790; 03/15 6005791; 03/15 6006005; 05/15 6006006; 05/15 6006091; 05/15 6006211; 06/15 6006212; 06/15 6006396; 07/15 6006397; 07/15
