The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0184-2016·Announced 2015-11-18

The Compounder Recalls Biest CP 76/24 DHEA Capsules Due to Penicillin Contamination

The Compounder is recalling Biest CP 76/24 DHEA capsules because an active ingredient was contaminated with penicillin. The recall is nationwide.

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, which corresponds to a Severe severity score under the rubric, particularly given the risk of penicillin cross-contamination in a drug product.

Plain-English summary

The Compounder is recalling Biest CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow) : Dehydroepiandrosterone Micronized (DHEA) 2.625 MG : 10 MG capsules. The recall is being conducted because the product was made using an active ingredient that was previously recalled by a supplier due to penicillin cross-contamination.

The affected product is a prescription-only medication containing 90 capsules per bottle. The specific lot number is 12312014:44@4, with an expiration date of 12/31/2015. The recall is distributed nationwide.

Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
BIEST CP 76/24: DHEA (Estriol USP Micronized (E3)/Estradiol (E2) Trit (Yellow) : Dehydroepiandrosterone Micronized (DHEA) 2.625 MG : 10 MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Manufacturer
the Compounder
Category
Drug — Prescription Medication
Hazard
Affected units
90

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 # 12312014:44@4
  • Exp 12/31/2015

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 contamination

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