The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1407-2015·Announced 2015-09-09

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.

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 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 →

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