The Recall Desk
HighFDA (Drugs)·D-0210-2016·Announced 2015-11-18

The Compounder Recalls Biest TD 86/14 Transdermal Cream Due to Penicillin Contamination

The Compounder is recalling Biest TD 86/14 transdermal cream because the active ingredient was contaminated with penicillin. Patients should stop using the product and consult their healthcare provider.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II and involves a high-risk allergen (penicillin) contamination without reported illnesses, meeting the criteria for a High severity score.

Plain-English summary

The Compounder is recalling Biest TD 86/14, a prescription transdermal cream containing estradiol and estriol. 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 product is dispensed in 3 mL prefilled, amber syringes. The specific lot number is 12102014:93@49, with an expiration date of 6/8/2015. The recall covers 20 syringes per unit, and the product was distributed nationwide.

Patients who have this product should stop using it and consult their healthcare provider. The recall is classified as FDA Class II, indicating that use of the product may cause temporary or medically reversible health consequences.

The recalled product

Product
BIEST TD 86/14 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) IN PLO GEL (Pluronic F127 20% or Polox 20% gel) 2.9 MG/ML Transdermal cream, dispensed in 3 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 # 12102014:93@49
  • Exp 6/8/2015

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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