The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0183-2016·Announced 2015-11-18

FDA Recalls Compounder Biest Troches Due to Penicillin Cross-Contamination

The Compounder is recalling Biest 80/20 troches because an active ingredient was contaminated with penicillin. Patients should stop using the product and consult 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 recall is classified as FDA Class II. According to the severity rubric, FDA Class II recalls with potential for significant injury (such as anaphylaxis from penicillin cross-contamination) are categorized as Severe (Score 4).

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Biest 80/20 : Progest : DHEA : Testost troches manufactured by The Compounder. The recall involves 60-troche packages of the prescription medication, specifically Lot # 12312014:91@6 with an expiration date of 3/31/2015. The product was distributed nationwide.

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. This contamination poses a risk of allergic reactions for patients with a penicillin allergy.

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

The recalled product

Product
BIEST 80/20 : PROGEST : DHEA : TESTOST (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow): Progesterone USP: Dehydroepiandrosterone Micronized (DHEA): Testosterone Trit ) 2.5 : 25 : 2.5 : 0.1MG TROCHE, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL…
Manufacturer
the Compounder
Category
Drug — Prescription Medication
Hazard
Affected units
60

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 # 12312014:91@6
  • Exp 3/31/2015

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 cross contamination

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