The Recall Desk
SevereFDA (Drugs)·D-0200-2016·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.

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' severity score under the rubric, particularly given the risk of penicillin cross-contamination in a drug product.

Plain-English summary

The Compounder is recalling 12 (10mL) syringes of BIEST TD 80/20 transdermal cream. The product is a prescription-only medication containing estradiol, estriol, progesterone, DHEA, and testosterone, dispensed in amber syringes.

The recall was initiated because the product was made using an active ingredient that was recalled by a supplier due to penicillin cross-contamination. The affected lot number is 01232015:29@51, with an expiration date of 7/22/2015. The product was distributed nationwide.

Consumers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

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 3: 25: 1.25: 0.25 MG/ML Transdermal cream, dispensed in 10 mL prefill
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 # 01232015:29@51
  • Exp 7/22/2015

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 →