FDA Drug Recalls

Recalls / Class II

Class IID-1068-2017

Product

Succinylcholine Chloride Injection Solution 10 mL, 200 mg/10 mL (20 mg/mL) Single-Dose Syringe, Rx Only, Cantrell Drug Company 7321 Cantrell Rd. Little Rock, AR 72207 877-666-5222, NDC 52533-067-12

Affected lot / code info
Lot #: 10078, BUD: 7/24/2017; 10111, BUD: 7/27/2017; 10125, BUD: 7/31/2017; 10143, BUD: 8/2/2017; 10166, BUD: 8/6/2017; 10191, BUD: 8/2/2017; 10195, BUD: 7/31/2017; 10221, BUD: 8/13/2017; 10297, BUD: 8/20/2017; 10376, BUD: 9/3/2017; 10398, BUD: 9/6/2017; 10432, BUD: 9/12/2017; 10447,10472, BUD: 9/14/2017; 10547, BUD: 9/27/2017; 10571, BUD: 10/3/2017

Why it was recalled

Lack of Sterility Assurance.

Recalling firm

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

Distribution

Quantity
57430 syringes
Distribution pattern
Nationwide within the US

Timeline

Recall initiated
2017-07-14
FDA classified
2017-08-09
Posted by FDA
2017-08-16
Terminated
2020-09-16
Status
Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-1068-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls