The Recall Desk
SevereFDA (Drugs)·D-0226-2016·Announced 2015-11-18

The Compounder Recalls TRIEST 70/20/10 Transdermal Cream Due to Penicillin Contamination

The Compounder is recalling TRIEST 70/20/10 transdermal cream because the active ingredient was contaminated with penicillin. The recall covers 24 syringes per lot.

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. Per the rubric, FDA Class II recalls with potential for adverse health consequences (such as penicillin contamination) are categorized as Severe (Score 4), as they are not Class I (Critical) but involve significant risk.

Plain-English summary

The Compounder is recalling TRIEST 70/20/10 (Estriol USP / Estradiol USP (E2) / Estrone (E1) Triturate) 12.5MG/ML transdermal cream. The product is dispensed in 1 mL prefilled amber syringes and is available by prescription only. The recall involves 24 syringes per lot, specifically Lot # 12222014:81@25 with an expiration date of 6/20/2015.

The recall was initiated because the active ingredient used to manufacture the product was recalled by a supplier due to penicillin cross-contamination. The distribution pattern for the affected product is nationwide.

Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for further instructions. The FDA classifies this recall as Class II, indicating a situation where use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
TRIEST 70/20/10 ( Estriol USP / Estradiol USP (E2) / Estrone (E1) Triturate) [909] 12.5MG/ML transdermal cream, dispensed in 1 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 # 12222014:81@25
  • Exp 6/20/2015

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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