Amneal Recalls Fosphenytoin Sodium Injection Due to Particulate Matter
Amneal Pharmaceuticals is recalling specific lots of Fosphenytoin Sodium Injection because of the presence of particulate matter.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA classified this recall as Class II. Per the rubric, FDA Class II recalls with potential for adverse health consequences are categorized as Severe.
Plain-English summary
Amneal Pharmaceuticals is recalling 12,584 vials of Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL. The product was distributed nationwide in the U.S. by Amneal Biosciences. The recall is being conducted due to the presence of particulate matter in the medication.
The affected product is identified by NDC 70121-1390-1. Specific lots involved in the recall include AP160022, AP160023, AP160038, AP160039, AP160040, AP160076, AP160077, and AP160078. These lots have expiration dates ranging from May 2018 to December 2018.
Healthcare providers and patients should check their inventory and discontinue use of the affected lots. The FDA has classified this recall as Class II, indicating that use of or exposure to the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
- Manufacturer
- Amneal Pharmaceuticals
- Category
- Drug — Injectable
- Hazard
- Affected units
- 12,584
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 (11)
- Lot #: AP160022
- AP160023
- Exp. 05/2018
- AP16038
- AP160039
- AP160040
- Exp. 06/2018
- AP160076
- AP160077
- AP160078
- Exp. 12/2018
Distribution
Distributed nationwide across the United States.
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