FDA recall D-417-2013

Product

Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244

Reason for recall

Lack of Assurance of Sterility; reports of adverse events after injection

Distribution

FL, MO, UT, and WA.

Key facts

Status

Terminated

Initiation date

2013-03-28

Report date

2013-05-22

Termination date

2016-10-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Dallas, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-417-2013