Drug 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.
D-1568-2014
Product summary
- Event
- Event 68191
- Status
- Terminated
- Classification
- Class I
- Quantity
- 5 Syringes
- Official record key
drug-enforcement:D-1568-2014
Official wording
Reason: Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Code information: Lot #: E0333282R; Exp: 7/13/2014
Distribution pattern: United States: TX, IL, MD, IN
Derived failure modes
-
Unknown
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.