The Recall Desk
SevereFDA (Drugs)·D-0191-2016·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. This recall affects nationwide distribution.

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 the presence of penicillin contamination in a medication poses a significant risk of severe allergic reactions, meeting the criteria for a Severe rating.

Plain-English summary

The Compounder is recalling Biest TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V 0.25 MG/ML Transdermal cream. The product is dispensed in 10 mL prefilled, amber syringes and is prescription-only. The recall involves 6 (10mL) syringes per unit, with Lot # 01262015:27@46 and an expiration date of 8/14/2015.

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 sensitive to penicillin.

The affected product was distributed nationwide. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider for further instructions or a replacement.

The recalled product

Product
BIEST TD 80/20 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 0.25 MG/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 # 01262015:27@46
  • Exp 8/14/2015

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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