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.
What this means for you
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.
- 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
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