Fresenius Kabi Recalls Fosphenytoin Sodium Injection Due to Glass Particulates
Fresenius Kabi USA, LLC is recalling Fosphenytoin Sodium Injection vials due to potential glass delamination and particulates.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a structural defect (glass delamination) in an injectable drug, which poses a significant risk of injury if administered.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 2,070,500 vials of Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL). The product is a prescription-only medication available in 2 mL single-use vials. The recall covers lots distributed nationwide and in Puerto Rico.
The recall was initiated because of the presence of particular matter, specifically potential glass delamination and glass particulates observed in sample vials. The affected lots include those manufactured between April 2014 and July 2015.
Healthcare providers and patients should stop using the affected vials and contact the manufacturer or their local FDA office for further instructions. The recall is classified as FDA Class II.
The recalled product
- Product
- FOSPHENYTOIN (FOSPHENYTOIN SODIUM)
- Brand
- FOSPHENYTOIN
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable
- Affected units
- 2,070,500
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
UPCs (2)
- 0363323403010
- 0363323403041
Distribution
Part of a larger recall action
This product is one of 2 recalled by Fresenius Kabi USA, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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