The Recall Desk
SevereFDA (Drugs)·D-0188-2016·Announced 2015-11-18

The Compounder Recalls Biest TD 50/50 Transdermal Cream Due to Penicillin Contamination

The Compounder is recalling Biest TD 50/50 transdermal cream because the 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. According to the rubric, FDA Class II recalls with potential for significant injury or adverse health consequences (such as penicillin contamination) are classified as Severe (Score 4).

Plain-English summary

The Compounder is recalling Biest TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V 4.0 MG/ML transdermal cream. The product is packaged in 3mL syringes and is available by prescription only. The recall affects 5 (3mL) syringes with Lot # 12232014:11@21 and an expiration date of 6/21/2015. The product was distributed nationwide.

The recall was initiated because the active ingredient used to manufacture the product was recalled by a supplier due to penicillin cross-contamination. This contamination poses a risk of allergic reactions or other adverse health effects for patients sensitive to penicillin.

Patients who have this product should stop using it immediately and contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
BIEST TD 50/50 (Estradiol USP Micronized (E2)/Estriol USP Micronized (E3)) W/V (weight /volume) 4.0 MG/ML transdermal cream packaged in 3mL 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 (2)

  • Lot # 12232014:11@21
  • Exp 6/21/2015

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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