The Recall Desk
SevereFDA (Drugs)·D-0215-2016·Announced 2015-11-18

The Compounder Recalls Estradiol Cream Due to Penicillin Cross-Contamination

The Compounder is recalling Estradiol, Progesterone, and DHEA 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 according to the rubric, particularly given the risk of penicillin cross-contamination.

Plain-English summary

The Compounder is recalling Estradiol (E3) : Progesterone : DHEA (Dehydroepiandrosterone Micronized) W/V Versabase 4.0 : 30 : 4mg/mL transdermal cream. The product is dispensed in 10 mL prefilled, amber syringes and is available by prescription only.

The recall was initiated because the active ingredient used to manufacture the product was recalled by a supplier due to penicillin cross-contamination. The affected lot is # 01282015:71@21, with an expiration date of 7/27/2015. The product was distributed nationwide.

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

The recalled product

Product
ESTRIOL (E3) : PROGESTERONE : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 4.0 : 30 : 4MG/ML Transdermal cream, dispensed in 10 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 (2)

  • Lot # 01282015:71@21
  • Exp 7/27/2015

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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