The Recall Desk
SevereFDA (Drugs)·D-0186-2016·Announced 2015-11-18

The Compounder Recalls BIEST CP 80/20 Capsules Due to Penicillin Contamination

The Compounder is recalling BIEST CP 80/20 capsules because the active ingredient was contaminated with penicillin. The recall is nationwide.

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 and involves penicillin cross-contamination, a significant hazard that can cause severe allergic reactions, meeting the criteria for a Severe rating.

Plain-English summary

The Compounder is recalling BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5 MG capsules. The recall is for 180-capsule bottles, Lot # 01162015:59@13, with an expiration date of 1/16/2016. The product is 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. Penicillin is a known allergen that can cause severe reactions in sensitive individuals.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance. The recall is classified as FDA Class II.

The recalled product

Product
BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 2.5 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Manufacturer
the Compounder
Category
Drug — Prescription Medication
Hazard
Affected units
180

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 # 01162015:59@13
  • Exp 1/16/2016

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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