Recalls / Class I
Class ID-1566-2014
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 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx Only. Labeled A) 50 mL, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd., Noblesville, IN 46060. NDC#: 45183-0989-41. B) 100 mL, Pharmakon Pharmaceuticals, 14450 Getz Rd., Noblesville, IN 888-660-6715. NDC#: 45183-0796-48.
- Affected lot / code info
- A) Lot #: E21294DK1C; Exp Date: 05/22/2014 B) Lot #: E21294DK3C; Exp Date: 06/08/2014
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
- 10/50 mL bags, 40/100 mL bags
- 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-1566-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.