FDA Drug Recalls

Recalls / Class II

Class IID-1162-2016

Product

Midazolam HCl in 0.9% Sodium Chloride Injection, 0.5 mg/mL 1 mL (0.5 mg/mL), 1 mL syringes, Rx Only, Cantrell Drug Co., Little Rock AR --- NDC 52533-157-45, UPC: 0100352533157455

Affected lot / code info
Lot: 6218, exp 9/17/15; 6877, exp 1/24/16

Why it was recalled

Subpotent Drug

Recalling firm

Firm
Cantrell Drug Company
Notification channel
E-Mail
Type
Voluntary: Firm initiated
Address
7321 Cantrell Rd, N/A, Little Rock, Arkansas 72207-4144

Distribution

Quantity
3853 syringes
Distribution pattern
Nationwide

Timeline

Recall initiated
2015-08-21
FDA classified
2016-07-06
Posted by FDA
2016-07-13
Terminated
2017-02-03
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1162-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.