The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1337-2015·Announced 2015-09-09

Bi-Est 80:20 Progesterone Capsules Recalled for Penicillin Cross Contamination

South Coast Specialty Compounding is recalling Bi-Est 80:20 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 agency classified the recall as Class II, and the hazard involves penicillin contamination, which poses a significant risk of allergic reaction or injury.

Plain-English summary

South Coast Specialty Compounding, Inc. is recalling Bi-Est 80:20 Progesterone (estriol, estradiol, progesterone) capsules, prescription only. The recall is being conducted because multiple finished products were potentially contaminated with penicillin.

The recall includes all lots of the product with an expiration date of 09/15. The products were distributed nationwide. The agency has classified this recall as Class II.

Consumers should stop using the recalled capsules and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
Bi-Est 80:20 Progesterone (estriol,estradiol, 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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Same manufacturer · South Coast Specialty Compounding, Inc.

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Same hazard · penicillin contamination

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