RecallRadar

FDA Drug recall D-0222-2016

ESTRIOL (E3) W/V (weight/volume) PGF 0.1% (1.0MG/ML) Transdermal cream, is dispensed in 3 mL prefilled, amber syringes, Rx only, The Compou…

On 2015-11-18 the FDA classified a Class II recall of ESTRIOL (E3) W/V (weight/volume) PGF 0.1% (1.0MG/ML) Transdermal cream, is dispensed in 3 mL prefilled, amber syringes, Rx only, The Compou… 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

AgencyFDA Drug
Recall numberD-0222-2016
ClassificationClass II
Statusterminated
Initiated2015-03-10
Published2015-11-18
Last updated2026-09-13 11:51 UTC
CompanyThe Compounder
DistributionUS

Product

ESTRIOL (E3) W/V (weight/volume) PGF 0.1% (1.0MG/ML) Transdermal cream, is dispensed in 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_infoLot # 12302014:27@3; use by 6/28/2015; and Lot # 02252015:26@3; use by 8/24/2015

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-0222-2016%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.