The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1408-2015·Announced 2015-09-09

South Coast Specialty Compounding Recalls Estradiol, Estriol, and Progesterone Capsules

South Coast Specialty Compounding is recalling Estradiol, Estriol, and Progesterone capsules 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 and involves potential penicillin contamination, which is a significant hazard for allergic patients, meeting the criteria for a Severe rating.

Plain-English summary

South Coast Specialty Compounding, Inc. is recalling Estradiol, Estriol, and Progesterone capsules, prescription-only products manufactured by Park Compounding in Irvine, California. The recall involves 2,370 capsules across 40 prescriptions, all with an expiration date of 09/15. The products were distributed nationwide.

The recall was initiated because multiple finished products were potentially contaminated with penicillin. This cross-contamination poses a risk to patients who may be allergic to penicillin.

Patients who have received these capsules should contact their healthcare provider or pharmacist for guidance on how to proceed. The recall is classified as Class II by the FDA.

The recalled product

Product
Estradiol, Estriol, Progesterone capsules, Rx only, Manufactured by Park Compounding, Irvine, CA
Manufacturer
South Coast Specialty Compounding, Inc.
Category
Drug — Compounded Prescription Medication
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

Same manufacturer · South Coast Specialty Compounding, Inc.

See all →

Same hazard · penicillin contamination

See all →

Similar recalls