Recalls / Class II

Class IID-978-2013

Product

METHYLCOBALAMIN 1 mg/ml, 5 mg/ml, 10 mg/ml, 25 mg/ml and METHYLCOBALAMIN (PF) 1 MG/ML, 25 MG/ML INJ SOLN, 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@14, 06052013@35, 07242013@8, 07242013@13, 04082013@11, 04292013@13, 02272013@9, 05212013@39, 03272013@28, 07032013@16, 02272013@8

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-978-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.