Recalls / Class I
Class ID-1362-2014
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 0.2 mg/2 mL 0.9% Sodium Chloride syringes, Total dosage: 0.4 mg per 2 mL, Rx Only, Pharmakon Pharmaceuticals, Inc., 14450 Getz Rd, Noblesville, Indiana, NDC 45183-0014-69.
- Affected lot / code info
- Lot #: E1016227C, Exp. 4/21/2014; E0433735C, Exp. 4/20/2014
Why it was recalled
Superpotent Drug: Product contains twice the stated amount of midazolam.
Recalling firm
- Firm
- Pharmakon Pharmaceuticals
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- 14450 Getz Rd, N/A, Noblesville, Indiana 46060-3303
Distribution
- Quantity
- 80 syringes
- Distribution pattern
- IN
Timeline
- Recall initiated
- 2014-03-26
- FDA classified
- 2014-06-09
- Posted by FDA
- 2014-06-18
- Terminated
- 2014-07-31
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1362-2014. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.