The Recall Desk
SevereFDA (Drugs)·D-0198-2016·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 an 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 agency classification is FDA Class II, and the hazard involves penicillin cross-contamination, which is a significant injury risk for sensitive individuals, meeting the criteria for a Severe rating.

Plain-English summary

The Compounder is recalling 26 prefilled 10 mL syringes of BIEST TD 80/20 transdermal cream. The product is a prescription-only compounded medication containing estradiol, estriol, progesterone, DHEA, and testosterone. The recall is limited to Lot # 12172014:08@24, which has an expiration date of 6/15/2015. The products were distributed nationwide.

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. This contamination poses a risk of allergic reactions or other adverse health effects for patients sensitive to penicillin.

Patients who have this specific lot of BIEST TD 80/20 should stop using the product immediately. They should contact their healthcare provider or pharmacist for further instructions and to discuss alternative treatment options. The recalled product should be returned to the pharmacy or disposed of according to local regulations.

The recalled product

Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) VERSABASE 5.0 : 30 : 2.5 : 0.25 MG/ML Transdermal cream, dispensed in 10 mL pre
Manufacturer
the Compounder
Category
Drug — Compounded 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 # 12172014:08@24
  • Exp 6/15/2015

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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