FDA recall D-1480-2016

Product

Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection, 10 mL multidose vial, sterile. Rx only. Compounded by Isomeric Pharmacy Solutions, Salt Lake City, UT 84109,

Reason for recall

Lack of Processing Controls: Isomeric Pharmacy Solution, LLC announces a voluntary field action for the Methylprednisolone Acetate/Lidocaine HCl 40/10 mg/mL Injection because the sterile injectable products were sterilized too long leading to potential difficulty resuspending particles.

Distribution

Nationwide and Puerto Rico. No Canadian, other foreign, govt/VA/military consignees.

Key facts

Status

Terminated

Initiation date

2016-06-29

Report date

2016-09-14

Termination date

2016-12-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Salt Lake City, UT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1480-2016