The Recall Desk
SevereFDA (Drugs)·D-0185-2016·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. Patients should stop using the product and consult 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 rated as Severe (4).

Plain-English summary

The Compounder is recalling BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 1.25 MG capsules. The recall was initiated because the product was manufactured using an active ingredient that was previously recalled by a supplier due to penicillin cross-contamination.

The affected product is a prescription-only medication available in 240-capsule bottles. The recall covers lots 02182015:78@22 and 02182015:98@23, both with an expiration date of February 18, 2016. The product was distributed nationwide.

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

The recalled product

Product
BIEST CP 80/20 (Estradiol (E2) Trit (Yellow)/Estriol USP Micronized (E3)) 1.25 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Manufacturer
the Compounder
Category
Drug — Prescription Medication
Hazard
Affected units
240

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 (3)

  • Lot # 02182015:78@22
  • Exp 2/18/2016
  • Lot # 02182015:98@23

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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