FDA recall D-0427-2015

Product

Hydroxocobalamin Injection Solution 1 mg/mL Inj., Rx, compounded by American Specialty Pharmacy, Plano, TX 75075 214-919-2090. NDC 99999-9994-27

Reason for recall

Presence of Particulate Matter; preservative may not have dissolved completely or precipitated out of product

Distribution

TX

Key facts

Status

Terminated

Initiation date

2014-12-12

Report date

2015-04-01

Termination date

2016-11-23

Voluntary/Mandated

Voluntary: Firm initiated

Location

Plano, TX, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0427-2015