The Recall Desk
SevereFDA (Drugs)·D-0216-2016·Announced 2015-11-18

The Compounder Recalls Estradiol and Progesterone Cream Due to Penicillin Contamination

The Compounder is recalling Estradiol and Progesterone 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 FDA classified this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury reports or structural defects are rated Severe (4). While no specific injuries are reported in the text, the presence of a known allergen (penicillin) in a prescription drug warrants a high severity rating due to the potential for severe allergic reactions.

Plain-English summary

The Compounder is recalling Estradiol and Progesterone transdermal cream, dispensed in 3 mL prefilled amber syringes. The recall involves 40 syringes per lot for two specific lots: Lot # 12172014:36@7 (Exp 6/15/2015) and Lot # 02202015:63@45 (Exp 8/19/2015). The product was distributed nationwide.

The recall was initiated because the active ingredient used to manufacture the cream was recalled by a supplier due to penicillin cross-contamination. This contamination poses a risk of allergic reactions for patients sensitive to penicillin.

Patients who have received this medication should contact their healthcare provider for guidance on discontinuing use and obtaining a replacement. The FDA has classified this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible adverse health consequences.

The recalled product

Product
ESTRIOL (E3) : PROGESTERONE W/V (weight/volume) 4.0 : 100 MG/ML Transdermal cream, 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 # 12172014:36@7
  • Exp 6/15/2015
  • Lot # 02202015:63@45
  • Exp 8/19/2015

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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