The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1414-2015·Announced 2015-09-09

Bi-Est Cream Recalled for Potential Penicillin Cross Contamination

South Coast Specialty Compounding is recalling Bi-Est cream due to potential penicillin cross contamination. The recall covers 36 prescriptions distributed nationwide.

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 agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls are assigned a score of 4 (Severe), particularly given the risk of penicillin contamination which can cause severe allergic reactions.

Plain-English summary

South Coast Specialty Compounding, Inc. is recalling Bi-Est (estriol, estradiol), Progesterone, Testosterone cream, a prescription-only product manufactured by Park Compounding in Irvine, CA. The recall is being conducted because multiple finished products are potentially contaminated with penicillin.

The recall involves 36 prescriptions that were distributed nationwide. The source text lists specific lot numbers and expiration dates associated with the affected units.

Consumers with this product should stop using it and contact their healthcare provider or pharmacist for instructions on how to proceed.

The recalled product

Product
Bi-Est (estriol,estradiol), Progesterone, Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Manufacturer
South Coast Specialty Compounding, Inc.
Category
Drug — Compounded Prescription Cream
Hazard
Affected units
36

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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