The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0214-2016·Announced 2015-11-18

The Compounder Recalls Estriol Capsules Due to Penicillin Contamination

The Compounder is recalling Estriol 4.0mg capsules because the active ingredient was contaminated with penicillin. Patients should stop using the product 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 agency classification is FDA Class II, and the hazard involves penicillin cross-contamination, which poses a significant risk of severe allergic reactions or anaphylaxis, meeting the criteria for a Severe rating.

Plain-English summary

The Compounder is recalling Estriol (E3) 4.0mg capsules, prescription only, in 90-capsule bottles. The recall is due to the use of an active ingredient that was previously recalled by a supplier because of penicillin cross-contamination.

The affected product is identified by Lot # 01142015:26@28 with an expiration date of 1/14/2016. The recall is nationwide.

Patients who have this medication should stop using it and consult their healthcare provider for further instructions.

The recalled product

Product
ESTRIOL (E3) 4.0MG 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 # 01142015:26@28
  • Exp 1/14/2016

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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