The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-1412-2015·Announced 2015-09-09

Bi-Est Testosterone Cream Recalled for Penicillin Cross Contamination

South Coast Specialty Compounding is recalling Bi-Est Testosterone cream due to potential penicillin cross-contamination. The affected products were 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 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) in a prescription drug, which poses a significant risk of harm to sensitive individuals, but no specific illnesses or injuries are reported in the source text.

Plain-English summary

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

The affected products were distributed nationwide. The recall covers 211 prescriptions associated with specific lot numbers and an expiration date of 07/15.

Consumers with this product should stop using it and consult their healthcare provider or pharmacist for guidance on disposal or replacement.

The recalled product

Product
Bi-Est (estriol,estradiol) Testosterone cream, Rx only, Manufactured by Park Compounding, Irvine, CA
Manufacturer
South Coast Specialty Compounding, Inc.
Category
Drug — Compounded Prescription Cream
Hazard
Affected units
211

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 →

Related recalls

Same manufacturer · South Coast Specialty Compounding, Inc.

See all →

Same hazard · allergen penicillin

See all →

Similar recalls