Recalls / Class I
Class ID-1568-2014
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Affected lot / code info
- Lot #: E0333282R; Exp: 7/13/2014
Why it was recalled
Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol.
Recalling firm
- Firm
- Pharmakon Pharmaceuticals
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14450 Getz Rd, N/A, Noblesville, Indiana 46060-3303
Distribution
- Quantity
- 5 Syringes
- Distribution pattern
- United States: TX, IL, MD, IN
Timeline
- Recall initiated
- 2014-04-21
- FDA classified
- 2014-08-26
- Posted by FDA
- 2014-09-03
- Terminated
- 2014-12-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1568-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.