FDA recall D-0224-2016

Product

ESTRIOL (E3) W/V (weight/volume) VERSABASE [4714] 0.05% (0.5MG/ML) transdermal cream, dispensed in a) 1 mL and b) 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.

Reason for recall

Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2015-03-10

Report date

2015-11-18

Termination date

2016-05-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Aurora, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0224-2016