Fresenius Kabi Recalls Fosphenytoin Sodium Injection Due to Glass Particulates
Fresenius Kabi USA, LLC is recalling 728,880 vials of Fosphenytoin Sodium Injection due to potential glass delamination and particulates.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a high-risk product (injectable medication) where injury has not yet been reported, but the hazard of glass particulates in an intravenous/intramuscular injection presents a significant risk of harm.
Plain-English summary
Fresenius Kabi USA, LLC is recalling 728,880 vials of Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL. The recall is being conducted because of the presence of particular matter, specifically potential glass delamination and glass particulates observed in sample vials.
The affected product is a prescription-only medication distributed nationwide and in Puerto Rico. The recall covers multiple lots with expiration dates ranging from April 2014 to November 2015. The specific lot numbers are listed in the structured product information provided by the agency.
Consumers and healthcare providers should stop using the affected vials and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the product. This recall is classified as Class II by the FDA.
The recalled product
- Product
- FOSPHENYTOIN (FOSPHENYTOIN SODIUM)
- Brand
- FOSPHENYTOIN
- Manufacturer
- Fresenius Kabi USA, LLC
- Category
- Drug — Injectable Medication
- Affected units
- 728,880
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 # 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
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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