South Coast Specialty Compounding Recalls Tri-Est 80:10:10 Capsules
South Coast Specialty Compounding is recalling Tri-Est 80:10:10 capsules due to potential penicillin cross-contamination. The affected products were 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 severity score of 4 (Severe), particularly when involving significant injury risks such as penicillin contamination.
Plain-English summary
South Coast Specialty Compounding, Inc. is recalling 2,380 capsules of Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules. The recall involves 39 prescriptions that were distributed nationwide. The specific products are identified as All Lots with an expiration date of 09/15.
The recall was initiated because multiple finished products were potentially contaminated with penicillin. This cross-contamination poses a risk to patients with penicillin allergies.
Consumers and healthcare providers should stop using the recalled capsules and contact their healthcare provider or pharmacist for guidance on alternative treatments or further instructions.
The recalled product
- Product
- Tri-Est 80:10:10 Progesterone (estriol, estradiol, estrone, progesterone) capsules Rx only, Manufactured by Park Compounding, Irvine, CA
- Manufacturer
- South Coast Specialty Compounding, Inc.
- Category
- Drug — Compounded Prescription
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- All Lots
- Exp 09/15
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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