The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0204-2016·Announced 2015-11-18

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

The Compounder is recalling BIEST TD 80/20 transdermal cream because it was made with an active ingredient contaminated with penicillin.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The agency classification is FDA Class II, and the hazard involves penicillin cross-contamination, which poses a significant risk of allergic reaction or anaphylaxis, meeting the criteria for a Severe rating.

Plain-English summary

The Compounder is recalling BIEST TD 80/20 transdermal cream, a prescription-only medication dispensed in 10 mL prefilled amber syringes. The product contains estradiol, estriol, progesterone, testosterone, and DHEA.

The recall was initiated because the product was manufactured using an active ingredient that was previously recalled by a supplier due to penicillin cross-contamination. The affected lots are # 01152015:68@24 (expiration date 7/14/2015) and # 02192015:15@12 (expiration date 8/18/2015). The recall covers 12 (10mL) syringes distributed nationwide.

Consumers with this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : TESTO (Testosterone USP) : DHEA (Dehydroepiandrosterone Micronized) W/V (weight/volume) VERSABASE 2.5 : 17.5 : 1.25 :0.25MG/ML Transdermal cream, dispensed in 10 mL…
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 (4)

  • Lot # 01152015:68@24
  • Exp 7/14/2015
  • and Lot # 02192015:15@12
  • Exp 8/18/2015

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 →

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Same hazard · penicillin contamination

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