FDA recall D-1060-2013

Product

Hydroxocobalamin MDV 5 mg/mL (5,000 mcg/mL) Inj., 10 mL vial X 3, Eastern States Compounding Pharmacy, Littleton, NH 03561

Reason for recall

Lack of Assurance of Sterility: The pharmacy is recalling one lot of Hydroxocobalamin MDV 5mg/mL due to failed sterility results by a third party contract testing lab. Hence the sterility of the product cannot be assured.

Distribution

CT

Key facts

Status

Terminated

Initiation date

2013-09-05

Report date

2013-09-25

Termination date

2013-09-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Littleton, NH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1060-2013