FDAFDA · Food and drugs·Recall number D-1568-2014
Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL pre-filled syringe, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Road, Noblesville, IN. NDC: 45183-0105-78.
Published September 3, 2014 · Recall initiated: April 21, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Pharmakon Pharmaceuticals
- Distributor
- United States: TX, IL, MD, IN
- Lot
- Lot #: E0333282R; Exp: 7/13/2014
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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