Reported Nov 30, 2022 · Terminated
Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per carton, NDC…
Acella Pharmaceuticals, LLC
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Acella Pharmaceuticals, LLC · 1880 Mcfarland Pkwy Ste 110 · Alpharetta, GA · 30005-1795
Is this the product you have?
Phenytoin Sodium InjectionUSP 100 mg/2 mLNDC 42192-614-02packaged in 10 x 2 mL vials per cartonNDC 42192-614-10Rx only
- Manufactured forAcella Pharmaceuticals, LLC Alpharetta, GA 30005
- Lot codes and dates
- LotE025A001 Exp. 07/2023
- Amount recalled
- 574 cartons
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
This product is unlikely to cause harm, but it breaks a safety or labelling rule.
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