Recalls / Class II

Class IID-939-2013

Product

B-COMPLEX/LIDOCAINE 2% INJECTION, all presentations, FOR INTRAVENO AND SQ USE ONLY, STERILE, RX ONLY, Compounded by Beacon Hill Medical Pharmacy PC, dba Rxtra Solutions, Southfield, MI

Affected lot / code info

04222013@23

Why it was recalled

Lack of Assurance of Sterility; FDA inspectional findings resulted in concerns associated with quality control procedures that impacted sterility assurance

Recalling firm

Firm

Beacon Hill Medical Pharmacy, P.C.

Notification channel

Telephone

Type

Voluntary: Firm initiated

Address

18161 W 13 Mile Rd, Suite A1, Southfield, Michigan 48076-1113

Distribution

Quantity

N/A

Distribution pattern

USA nationwide

Timeline

Recall initiated

2013-07-26

FDA classified

2013-09-10

Posted by FDA

2013-09-18

Terminated

2014-07-18

Status

Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-939-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.