FDA recall D-0728-2016

Isomeric Pharmacy Solution, LLC · Class III · drug

Product

Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 10mL Multi-Dose Vial for Injection, Rx only, Isomeric Pharmacy Solutions, 2401 Foothill Dr., Salt Lake City, UT 84109

Reason for recall

Labeling: Incorrect or Missing Lot and/or Exp Date: some vials may be mislabeled with an incorrect "Compounded" date, lot number, and "Do Not Use Beyond" date or BUD (Before Use Date) that may be longer than intended.

Distribution

Nationwide

Key facts

Status
Terminated
Initiation date
2016-02-02
Report date
2016-03-02
Termination date
2016-05-03
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-0728-2016