The Recall Desk
SevereFDA (Drugs)·D-0197-2016·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 recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the risk of allergic reaction from penicillin contamination.

Plain-English summary

The Compounder is recalling BIEST TD 80/20 transdermal cream, a prescription medication dispensed in 10 mL prefilled syringes. The recall involves 18 syringes from Lot # 12112014:43@19, which has an expiration date of 6/9/2015. The product was distributed nationwide.

The recall was initiated because the product was made using an active ingredient that was recalled by a supplier due to penicillin cross-contamination. This contamination poses a risk of allergic reactions for patients with penicillin allergies.

Patients who have received this specific lot of BIEST TD 80/20 should stop using the product immediately and contact their healthcare provider for further instructions. The recalling firm is The Compounder, located in Aurora, Illinois.

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 2.5: 30 : 2.5 : 0.25 MG/MLTransdermal cream, dispensed in 10 mL prefi
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 # 12112014:43@19
  • Exp 6/9/2015

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

See all →

Same hazard · penicillin contamination

See all →