The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1415-2015·Announced 2015-09-09

Bi-Est and Progesterone Vaginal Suppositories Recalled for Penicillin Contamination

South Coast Specialty Compounding is recalling Bi-Est and Progesterone Vaginal Suppositories due to potential penicillin cross-contamination.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric, particularly given the risk of penicillin allergy in a drug product.

Plain-English summary

South Coast Specialty Compounding, Inc. is recalling Bi-Est (estriol, estradiol) and Progesterone Vaginal Suppositories. The recall is being conducted because multiple finished products are potentially contaminated with penicillin.

The affected products are prescription-only vaginal suppositories manufactured by Park Compounding in Irvine, California. The recall covers 24 suppositories per prescription, with specific lot numbers and expiration dates listed in the official notice. The products were distributed nationwide.

Consumers who have these products should stop using them and contact their healthcare provider or pharmacist for instructions on how to dispose of the medication or obtain a replacement.

The recalled product

Product
Bi-Est (estriol,estradiol), Progesterone Vaginal Suppository, Rx only, Manufactured by Park Compounding, Irvine, CA
Manufacturer
South Coast Specialty Compounding, Inc.
Category
Drug — Compounded Prescription
Hazard

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 →

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