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.
What this means for you
Illness, injury, or structural failure has been reported. 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.
- 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 →Related recalls
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