The Recall Desk
SevereFDA (Drugs)·D-0203-2016·Announced 2015-11-18

FDA Recalls BIEST TD 80/20 Cream Due to Penicillin Contamination

The Compounder is recalling BIEST TD 80/20 transdermal cream because an active ingredient was contaminated with penicillin. Patients should stop using the product and consult 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. Per the rubric, FDA Class II recalls with potential for significant injury (such as allergic reactions to penicillin) are rated as Severe (4).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for BIEST TD 80/20 transdermal cream, manufactured by The Compounder. The recall involves 18 prefilled 10 mL syringes of the product, identified by Lot # 02252015:80@18 and an expiration date of 8/24/2015. The product was distributed nationwide.

The recall was initiated because the product was made using an active ingredient that was previously recalled by a supplier due to penicillin cross-contamination. Penicillin is a common allergen, and exposure can cause adverse reactions in sensitive individuals.

Patients who have this specific lot of BIEST TD 80/20 should stop using the product immediately and contact their healthcare provider for further instructions. The recall is classified as Class II, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) IN VERSABASE W/V (weight/volume) 4 : 67.5 :10MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,
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 # 02252015:80@18
  • Exp 8/24/2015

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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