The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0227-2016·Announced 2015-11-18

The Compounder Recalls TRIEST 80/10/10 Capsules Due to Penicillin Contamination

The Compounder is recalling TRIEST 80/10/10 capsules because the active ingredient was contaminated with penicillin. Patients should stop using the medication and consult a 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 and involves penicillin cross-contamination, which poses a significant risk of allergic reaction or serious injury, meeting the criteria for a Severe rating.

Plain-English summary

The Compounder is recalling TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / Estriol USP (E3)) 5MG capsules. The recall is being conducted because the active ingredient used to manufacture the product was recalled by a supplier due to penicillin cross-contamination.

The affected product is a prescription-only medication available in 120-capsule bottles. The recall covers specific lots: Lot # 12302014:78@17 with an expiration date of 12/30/2015, and Lot # 03032015:04@4 with an expiration date of 3/2/2016. The product was distributed nationwide.

Consumers who have this medication should stop using it and consult their healthcare provider. The FDA has classified this recall as Class II, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
TRIEST 80/10/10 (E1/E2 Trit - Estrone (E1)/Estradiol (E2) / Estriol USP (E3)) (23) 5MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Manufacturer
the Compounder
Category
Drug — Prescription Medication
Hazard
Affected units
120

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 (4)

  • Lot # 12302014:78@17
  • Exp 12/30/2015
  • Lot # 03032015:04@4
  • Exp 3/2/2016

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 →

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