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.
Reported: September 3, 2014 Initiated: April 21, 2014 #D-1568-2014
Product Description
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.
Details
- Recalling Firm
- Pharmakon Pharmaceuticals
- Units Affected
- 5 Syringes
- Distribution
- United States: TX, IL, MD, IN
- Location
- Noblesville, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Pharmakon Pharmaceuticals. Units affected: 5 Syringes.
Why was this product recalled? ▼
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 3, 2014. Severity: Critical. Recall number: D-1568-2014.
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