FDA-Drug2022-11-30Class III
Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Acella Pharmaceuticals, LLC
Hazard
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Sold states
Nationwide in the USA.
Affected count
637 cartons
Manufactured in
1880 Mcfarland Pkwy Ste 110, N/A, Alpharetta, GA, United States
Products
Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0070-2023Don't want to check this manually?
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