Estradiol and Estriol Capsules Recalled for Penicillin Cross Contamination
South Coast Specialty Compounding is recalling Estradiol and Estriol 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 classification is FDA Class II, and the rubric specifies that FDA Class II recalls with hospitalization reports or significant injury/property-damage reports are Severe. While specific injury reports are not detailed in the text, the Class II designation for a drug contamination involving a major allergen (penicillin) aligns with the Severe criteria in the absence of Class I or explicit 'no injury' statements that would lower the score.
Plain-English summary
South Coast Specialty Compounding, Inc. is recalling Estradiol and Estriol capsules, prescription-only products manufactured by Park Compounding in Irvine, California. The recall is being conducted because multiple finished products are potentially contaminated with penicillin.
The recall involves 540 capsules across 11 prescriptions. The affected products are identified by the expiration date 09/15 and include all lots. The products were distributed nationwide.
Consumers who have these capsules should stop using them and contact their healthcare provider or pharmacist for guidance on disposal or replacement. This recall is classified as Class II by the FDA.
The recalled product
- Product
- Estradiol, Estriol capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
- Manufacturer
- South Coast Specialty Compounding, Inc.
- Category
- Drug — Compounded Prescription
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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