The Recall Desk
SevereFDA (Drugs)·D-0218-2016·Announced 2015-11-18

FDA Recalls Compounder Transdermal Cream Due to Penicillin Contamination

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

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 source text identifies this as an FDA Class II recall involving penicillin cross-contamination, which poses a risk of allergic reaction or anaphylaxis. Per the rubric, FDA Class II recalls involving significant injury risks or hospitalization potential are classified as Severe.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a Class II recall for a compounded transdermal cream manufactured by The Compounder. The product is a prescription-only cream containing estradiol, estradiol trinitrate, progesterone, and testosterone, dispensed in 10 mL prefilled amber syringes.

The recall was initiated because the product was made using an active ingredient that was previously recalled by a supplier due to penicillin cross-contamination. The specific lot number is 01162015:90@26, with an expiration date of July 15, 2015. The affected quantity is five 10 mL syringes per unit, and the product was distributed nationwide.

Patients who have received this specific compounded cream should contact their healthcare provider or pharmacist for guidance on discontinuing use and obtaining a replacement if necessary. The FDA classifies this as a Class II recall, indicating that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
ESTRIOL (E3) : ESTRADIOL (E2) (Estradiol (E2) Trit (Yellow)) : PROGEST (Progesterone USP) : TESTO (Testosterone USP) W/V (weight/volume) 2 :0.1 : 30 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100,
Manufacturer
the Compounder
Category
Drug — Compounded Prescription
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 (2)

  • Lot # 01162015:90@26
  • Exp 7/15/2015

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 →

Related recalls

Same manufacturer · the Compounder

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Same hazard · penicillin contamination

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