The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0199-2016·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.

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 rubric specifies that FDA Class II recalls with potential for significant injury or hospitalization (implied by penicillin cross-contamination in a drug product) fall under the Severe category.

Plain-English summary

The Compounder is recalling BIEST TD 80/20 transdermal cream, a prescription medication dispensed in 10 mL prefilled amber syringes. The recall was initiated because the product was made using an active ingredient that was previously recalled by a supplier due to penicillin cross-contamination.

The affected product is identified by Lot # 01132015:45@15 with an expiration date of 7/12/2015. The recall covers 6 (10mL) syringes distributed nationwide.

Patients who have this product should stop using it immediately and contact their healthcare provider or pharmacist 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) : PROG (Progesterone USP Micronized) : DHEA (Dehydroepiandrosterone Micronized) : TESTO (Testosterone Trit) W/V (weight/volume) 2.5 : 20 : 1.25 : 0.25 MG/ML TRANSDERMAL (Cream)Transdermal cream, dispensed…
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 # 01132015:45@15
  • Exp 7/12/2015

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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