drugs Class II Updated 2014-07-16

Fresenius Kabi USA, LLC recalls Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE

Recalled 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

Hazard / Issue

Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
View official government recall

Looking for safe alternatives?

Browse certified-safe products in this category on Amazon →

Related drugs Recalls

Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Deliver

2012-06-20 · Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Ben Venue Laboratories Inc recalls Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, pac

2012-06-20 · Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.

Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Deliver

2012-06-20 · Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Deliver

2012-06-20 · Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.