The Recall Desk
SevereFDA (Drugs)·D-0217-2016·Announced 2015-11-18

The Compounder Recalls Transdermal Cream Due to Penicillin Cross-Contamination

The Compounder is recalling specific lots of a compounded transdermal cream because an 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 agency classification is FDA Class II, and the hazard involves penicillin cross-contamination, which poses a risk of significant allergic reaction or injury.

Plain-English summary

The Compounder is recalling a specific lot of a compounded transdermal cream containing estradiol, progesterone, and testosterone. The product is dispensed in 10 mL prefilled amber syringes and is available by prescription only.

The recall was initiated because the product was manufactured using an active ingredient that was previously recalled by a supplier due to penicillin cross-contamination. The affected lot is identified as Lot # 01132015:27@20, with an expiration date of 7/12/2015. The recall covers 6 (10mL) syringes distributed nationwide.

Consumers who have this specific product should stop using it and contact their healthcare provider or pharmacist for guidance on disposal or replacement.

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 : 35 : 0.5 MG/ML Transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 10
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 # 01132015:27@20
  • Exp 7/12/2015

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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