The Recall Desk
SevereFDA (Drugs)·D-0193-2016·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 the active ingredient was contaminated with penicillin. Patients should stop using the product and consult 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. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly given the risk of penicillin cross-contamination which can cause severe allergic reactions.

Plain-English summary

The Compounder is recalling Biest TD 80/20 (estradiol/estriol) transdermal cream, a prescription-only medication dispensed in 3 mL and 10 mL prefilled amber syringes. The recall is being conducted because the active ingredient used to manufacture the product was recalled by a supplier due to penicillin cross-contamination.

The affected products were distributed nationwide. Specific lot numbers and expiration dates are listed in the recall documentation. The recall involves 30 units of the 3 mL syringes and 9 units of the 10 mL syringes.

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

The recalled product

Product
BIEST TD 80/20 (estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) W/V (weight/volume) 2.5MG/ML Transdermal cream, dispensed in a) 3 mL and b) 10 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 (6)

  • a) Lot # 12162014:22@32
  • Exp 6/14/2015
  • Lot # 01122015:42@45
  • Exp 7/11/2015
  • b) Lot # 01212015:65@5
  • Exp 7/20/2015

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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