The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1411-2015·Announced 2015-09-09

FDA Recalls Estriol and Estradiol Cream Due to Penicillin Contamination

South Coast Specialty Compounding is recalling 61 prescriptions of Estriol and Estradiol cream because the products may be 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 FDA classifies this as a Class II recall. Per the rubric, FDA Class II recalls involving significant injury risks or specific contamination hazards are categorized as Severe (Score 4), particularly when the agency's own classification is Class II and the hazard involves a known allergen like penicillin.

Plain-English summary

The U.S. Food and Drug Administration (FDA) has issued a recall for Estriol and Estradiol cream, a prescription-only product manufactured by Park Compounding in Irvine, California. The recalling firm is South Coast Specialty Compounding, Inc. The recall involves 61 prescriptions distributed nationwide.

The recall was initiated because multiple finished products are potentially contaminated with penicillin. This cross-contamination poses a risk to patients who may be allergic to penicillin. The affected lots have expiration dates of 07/15 and specific lot numbers are listed in the official recall documentation.

Consumers who have this product should stop using it immediately and contact their healthcare provider or pharmacist for guidance. The FDA classifies this recall as Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.

The recalled product

Product
Estriol,Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Manufacturer
South Coast Specialty Compounding, Inc.
Category
Drug — Compounded Prescription Cream
Hazard
Affected units
61

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 15 recalled by South Coast Specialty Compounding, Inc. 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 15 products in this recall →

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