The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0222-2016·Announced 2015-11-18

The Compounder Recalls Estriol Cream Due to Penicillin Cross-Contamination

The Compounder is recalling specific lots of Estriol transdermal cream because the active ingredient was contaminated with penicillin.

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 the presence of penicillin cross-contamination in a transdermal product poses a significant risk of severe allergic reactions or anaphylaxis, meeting the criteria for a Severe rating.

Plain-English summary

The Compounder is recalling 10 (3mL) syringes of ESTRIOL (E3) W/V (weight/volume) PGF 0.1% (1.0MG/ML) Transdermal cream. The recall affects Lot # 12302014:27@3 (use by 6/28/2015) and Lot # 02252015:26@3 (use by 8/24/2015). The product is dispensed in 3 mL prefilled, amber syringes and is available by prescription only.

The recall was initiated because the active ingredient used to manufacture the cream was recalled by a supplier due to penicillin cross-contamination. The distribution of the affected product was nationwide.

Consumers who have these specific lots of the 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
ESTRIOL (E3) W/V (weight/volume) PGF 0.1% (1.0MG/ML) Transdermal cream, is dispensed in 3 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Manufacturer
the Compounder
Category
Drug — Transdermal Cream
Hazard

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 # 12302014:27@3
  • use by 6/28/2015
  • and Lot # 02252015:26@3
  • use by 8/24/2015

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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