FDA Recall D-1568-2014
Pharmakon Pharmaceuticals · Noblesville, IN
Class I — life-threatening Terminated 226 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
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.
Reason for recall
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Recall record
- Recall number
D-1568-2014- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Telephone
- Distribution
- United States: TX, IL, MD, IN
- Recall initiated
- 2014-04-21
- Classified by FDA Center
- 2014-08-26
- FDA published
- 2014-09-03
- Terminated
- 2014-12-03
- Recalling firm
- Pharmakon Pharmaceuticals
- Firm location
- Noblesville, IN