The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-1410-2015·Announced 2015-09-09

Bi-Est Hormone Drops Recalled for Potential Penicillin Cross Contamination

South Coast Specialty Compounding is recalling five prescriptions of Bi-Est hormone drops 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 classification is FDA Class II, and the hazard involves potential penicillin contamination, which poses a significant risk of allergic reaction or anaphylaxis, meeting the criteria for a Severe rating.

Plain-English summary

South Coast Specialty Compounding, Inc. is recalling five prescriptions of Bi-Est (estriol, estradiol), Progesterone, DHEA, and Testosterone drops. The recall is being issued because multiple finished products were potentially contaminated with penicillin.

The affected products are prescription-only drops manufactured by Park Compounding in Irvine, California. The recall covers specific lots with expiration dates of 07/15. The distribution pattern is listed as nationwide.

Consumers who have these specific prescriptions should stop using the product and contact their healthcare provider or pharmacist for further instructions.

The recalled product

Product
Bi-Est (estriol,estradiol), Progesterone, DHEA, Testosterone drops, Rx only, Manufactured by Park Compounding, Irvine, CA
Manufacturer
South Coast Specialty Compounding, Inc.
Category
Drug — Compounded Prescription
Hazard
Affected units
5

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 (5)

  • Lot # 01152015@20
  • 03032015@22
  • 03092015@55
  • 12052014@20
  • Exp 07/15

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