The Recall Desk
SevereFDA (Drugs)·D-0212-2016·Announced 2015-11-18

The Compounder Recalls Biest TD 91/9 Transdermal Cream Due to Penicillin Contamination

The Compounder is recalling specific lots of Biest TD 91/9 transdermal cream because the 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. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving contamination risks that could lead to hospitalization or significant injury.

Plain-English summary

The Compounder is recalling specific lots of Biest TD 91/9 transdermal cream. The product is a prescription-only medication containing estriol, estradiol, and progesterone, dispensed in 10 mL prefilled amber syringes.

The recall was initiated because the active ingredient used to manufacture the recalled products was recalled by a supplier due to penicillin cross-contamination. The affected lots are identified as Lot # 12242014:95@3 (Expiration 6/22/2015) and Lot # 02042015:29@7 (Expiration 8/3/2015).

The recall is classified as FDA Class II. Consumers and healthcare providers should check their inventory for these specific lot numbers and discontinue use if found.

The recalled product

Product
BIEST TD 91/9 (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow)) : PROGESTERONE W/V (weight/volume) PLO (Pluronic F127 20% or Polox 20% gel) 3.3 MG/ML : 40 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue
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 (4)

  • Lot # 12242014:95@3
  • Exp 6/22/2015
  • Lot # 02042015:29@7
  • Exp 8/3/2015

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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