The Recall Desk
SevereFDA (Drugs)·D-0195-2016·Announced 2015-11-18

The Compounder Recalls Biest TD 80/20 Transdermal Cream Due to Penicillin Contamination

The Compounder is recalling Biest TD 80/20 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and contact their healthcare provider.

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 and involves a significant injury risk (penicillin cross-contamination) which aligns with the 'Severe' criteria for significant injury reports or high-risk contamination.

Plain-English summary

The Compounder is recalling Biest TD 80/20 (Estriol USP Micronized/Estradiol) transdermal cream, dispensed in 1 mL prefilled amber syringes. The recall involves 36 syringes per lot, specifically Lot # 12222014:95@21 with an expiration date of 6/20/2015. The product was distributed nationwide.

The recall was initiated because the active ingredient used to manufacture the product was recalled by a supplier due to penicillin cross-contamination. This contamination poses a risk of allergic reactions for patients with penicillin allergies.

Patients who have this product should stop using it immediately and contact their healthcare provider for further instructions. The recall is classified as Class II by the FDA.

The recalled product

Product
BIEST TD 80/20 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) W/V(weight/volume) [2977] 6.25MG/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 # 12222014:95@21
  • 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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