Recalls / Class I
Class ID-1565-2014
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
Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville IN 46060 NDC#: 45183-0234-68.
- Affected lot / code info
- Lot #: E21294K3C Exp Date: 6/29/2014
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
- 20 vials
- 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-1565-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.