The Recall Desk
HighFDA (Drugs)·D-0213-2016·Announced 2015-11-18

The Compounder Recalls Hormone Capsules Due to Penicillin Cross-Contamination

The Compounder is recalling specific lots of compounded hormone capsules because an active ingredient was contaminated with penicillin.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a high-risk allergen (penicillin) contamination in a drug product. Per the rubric, risk-of-harm products where injury has not yet been reported are classified as High (Score 3).

Plain-English summary

The Compounder is recalling 120-capsule bottles of a compounded prescription medication containing estradiol, estriol, progesterone, and testosterone. The recall is limited to Lot # 02172015:64@24, which has an expiration date of 5/18/2015.

The recall was initiated because the product was manufactured using an active ingredient that was previously recalled by a supplier due to penicillin cross-contamination. The source text does not specify the number of units distributed or the specific geographic locations where the product was sold, though the distribution pattern is listed as nationwide.

Consumers who have this specific lot of medication should stop using it and contact their healthcare provider or pharmacist for further instructions. The source text does not report any illnesses or injuries associated with this recall.

The recalled product

Product
E2 (Estradiol (E2) Trit (Yellow) : E3 (Estriol USP Micronized (E3) : PROGEST (Progesterone USP Micronized) : TESTOST (Testosterone USP) IN OLIVE OIL 0.75 : 3 : 50 : 5MG capsules, Rx only, The Compounder, 340 Marshall Avenue Unit 100, Aurora, IL 60506.
Manufacturer
the Compounder
Category
Drug — Compounded Prescription
Hazard
Affected units
120

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)

  • Lot # 02172015:64@24
  • Exp 5/18/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 47 recalled by the Compounder 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 47 products in this recall →

Related recalls

Same manufacturer · the Compounder

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Same hazard · penicillin allergy

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