The Recall Desk
SevereFDA (Drugs)·D-0220-2016·Announced 2015-11-18

FDA Recalls Estradiol and Testosterone Cream Due to Penicillin Contamination

The Compounder is recalling Estradiol and Testosterone transdermal cream because the active ingredient was contaminated with penicillin.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the risk of penicillin cross-contamination.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for Estradiol (E3) and Testosterone transdermal cream manufactured by The Compounder. The product is dispensed in 3 mL prefilled, amber syringes and is available by prescription only.

The recall was initiated because the active ingredient used to make the product was recalled by a supplier due to penicillin cross-contamination. The affected lots are # 12292014:45@12 (Exp 6/27/2015), # 01282015:06@16 (Exp 7/27/2015), and # 03022015:06@38 (Exp 8/29/2015). The recall covers 30 (3mL) syringes distributed nationwide.

Consumers with this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to return or dispose of the medication.

The recalled product

Product
ESTRIOL (E3) : TESTO (Testosterone USP) WV (weight/volume) 0.5MG : 2MG/ML Transdermal cream, dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Manufacturer
the Compounder
Category
Drug — Transdermal Cream
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • Lot # 12292014:45@12
  • Exp 6/27/2015
  • Lot # 01282015:06@16
  • Exp 7/27/2015
  • Lot # 03022015:06@38
  • Exp 8/29/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 47 recalled by the Compounder under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 47 products in this recall →

Related recalls

Same manufacturer · the Compounder

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Same hazard · penicillin contamination

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