Amneal Pharmaceuticals recalls Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ…
- Recall date
- December 15, 2017
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-0610-2018
- FDA classification
- Class II
- Brand / firm
- Amneal Pharmaceuticals
- Sold / distributed
- U.S.A Nationwide
Why it was recalled
Presence of particulate matter
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1
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