Acella Pharmaceuticals, LLC 2022-11-30 Health moderate FDA
Health · FDA · Recall #FDA-D-0070-2023
Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL… Recall
Issued November 30, 2022 · Acella Pharmaceuticals, LLC
In November 2022, Acella Pharmaceuticals, LLC recalled the Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL…, a moderate health recall reported by the FDA.
Compiled by Maya Ellison, RecallCheckr
What this means for you
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
What you should do
- 1 Stop using Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL… right away.
- 2 Set it aside where it won't be used by mistake.
- 3 Contact Acella Pharmaceuticals, LLC to arrange your voluntary. See the official notice below for contact details.
- 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):
Recall details
- Brand
- Acella Pharmaceuticals, LLC
- Category
- Health
- Recall date
- November 30, 2022
- Units affected
- Not reported
- Sold at
- Nationwide in the USA.
- Recall number
- FDA-D-0070-2023
- Made in
- United States
- Issuing agency
- FDA
In context
- Acella Pharmaceuticals, LLC has 4 recalls in our database.
- We're tracking 3,576 Health recalls in our database.
- This is the 870th Health recall we've logged in 2022.