The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1413-2015·Announced 2015-09-09

Estradiol Cream Recalled for Potential Penicillin Cross Contamination

South Coast Specialty Compounding is recalling 24 prescriptions of Estradiol cream due to potential penicillin cross contamination.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk allergen (penicillin) contamination in a medication, which poses a significant risk of harm, but no specific injuries or illnesses are reported in the source text.

Plain-English summary

South Coast Specialty Compounding, Inc. is recalling 24 prescriptions of Estradiol cream, a prescription-only medication manufactured by Park Compounding in Irvine, California. The recall is being conducted because multiple finished products are potentially contaminated with penicillin.

The affected products were distributed nationwide. The recall covers specific lots with expiration dates of 07/15, including lot numbers 01022015@21, 01022015@41, 01052015@61, and others listed in the official notice.

Consumers with this product should stop using it and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Estradiol cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Manufacturer
South Coast Specialty Compounding, Inc.
Category
Drug — Compounded Prescription
Hazard
Affected units
24

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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