Amneal Recalls Fosphenytoin Sodium Injection Due to Particulate Matter
Amneal Pharmaceuticals is recalling 14,000 vials 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential adverse health consequences from particulate matter in an injectable drug.
Plain-English summary
Amneal Pharmaceuticals LLC is recalling 14,000 vials of Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL. The product is a 10 mL single-dose vial intended for prescription use only. The specific lot number is AP160016, and the expiration date is 05/18.
The recall was initiated due to the presence of particulate matter in the product. This is a Class II recall, indicating a situation where 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.
The affected product was distributed in Mississippi, North Carolina, Ohio, Texas, and Utah. Healthcare providers and patients should stop using the recalled product and contact their pharmacist or the manufacturer for a replacement or refund.
The recalled product
- Product
- Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL. 10 mL Single Dose Vial, Rx Only. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807. NDC: 70121-1390-7
- Manufacturer
- Amneal Pharmaceuticals LLC
- Category
- Drug — Injectable
- Hazard
- Affected units
- 14,000
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 (2)
- Lot # AP160016
- Exp. 05/18
Distribution
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