The Recall Desk
SevereFDA (Drugs)·D-0225-2016·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 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 agency classification is FDA Class II, and the hazard involves penicillin cross-contamination, which poses a risk of significant allergic reactions or injury.

Plain-English summary

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

The recall was initiated because the active ingredient used to manufacture the recalled products was recalled by a supplier due to penicillin cross-contamination. The affected lots are identified as Lot # 12182014:10@21 (Expiration 6/16/2015) and Lot # 01292015:64@13 (Expiration 7/28/2015).

The recall is distributed nationwide. Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.

The recalled product

Product
ESTRIOL 5 ESTRADIOL (Estradiol (E2) Trit (Yellow)) 0.95 ESTRONE (Estrone E1) Trit (Red)) 0.02 TEST (Testosterone USP) 0.75MG/ML W/V (weight/volume) transdermal cream, dispensed in 10 mL prefilled, amber syringes, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL
Manufacturer
the Compounder
Category
Drug — Compounded 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 # 12182014:10@21
  • Exp 6/16/2015
  • Lot # 01292015:64@13
  • Exp 7/28/2015

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

See all →

Same hazard · penicillin contamination

See all →