The Recall Desk
SevereFDA (Drugs)·D-0202-2016·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. The hazard involves penicillin cross-contamination, a significant risk for patients with penicillin allergies.

Plain-English summary

The Compounder is recalling specific lots of Biest TD 80/20 transdermal cream. This prescription-only medication contains estradiol, estriol, progesterone, and DHEA. The recall was initiated because an active ingredient used in the manufacturing process was recalled by a supplier due to penicillin cross-contamination.

The affected product is dispensed in 10 mL prefilled, amber syringes. The recall covers specific lot numbers with expiration dates in 2015. The distribution of the recalled product was nationwide.

Patients who have this product should stop using it immediately and contact their healthcare provider for further instructions. The recall is being managed by the U.S. Food and Drug Administration.

The recalled product

Product
BIEST TD 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) IN VERSABASE W/V (weight/volume) 2.5 : 25 :1.25MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only,
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 (6)

  • Lot # 02022015:66@40
  • Exp 8/1/2015
  • Lot # 03022015:62@26
  • Exp 8/29/2015
  • Lot # 03062015:66@10
  • Exp by 9/2/2015

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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