FDA Drug recall D-0224-2016
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 syr…
- FDA Drug
- Class II
- terminated
- Published 2015-11-18
On 2015-11-18 the FDA classified a Class II recall of 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 syr… by The Compounder, citing recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0224-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-03-10 |
| Published | 2015-11-18 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | The Compounder |
| Distribution | US |
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
Recalled products were made using an active ingredient that was recalled by a supplier due to penicillin cross contamination.
Identifiers
| code_info | a) Lot # 12292014:32@20, Exp 6/27/2015; b) Lot # 01082015:73@21, Exp 7/7/2015 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0224-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.