Agency classClass IIOur severity:Severe FDA (Drugs)·D-1467-2015·Announced 2015-09-23

Estradiol Pellets Recalled Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Estradiol 15 mg sterile pellets nationwide because FDA inspections identified GMP violations affecting sterility.

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. The hazard involves a sterile medical product with GMP violations impacting sterility, which poses a significant risk of serious injury (infection) if used, fitting the 'Severe' criteria for significant injury risk or Class II with potential for serious harm.

Plain-English summary

The Compounding Pharmacy of America is recalling Estradiol 15 mg, Sterile Pellets, manufactured in Knoxville, Tennessee. The recall covers 120-pellet packages distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the official recall notice.

The recall was initiated due to a lack of assurance of sterility. An FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. No specific illnesses or injuries are reported in the source text.

Consumers who have purchased these products should stop using them and contact their healthcare provider or the recalling firm for instructions on return or replacement.

The recalled product

Product: Estradiol 15 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Compounded Sterile Product
Hazard: sterility
gmp-violation
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 (11)

All lots distributed between November 2014 and May 2015
11262014@20
5/25/2015
01152015@27
7/14/2015
02232015@21
8/22/2015
02242015@23
8/23/2015
05052015@68
11/1/2015

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 382 recalled by The Compounding Pharmacy of America 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 382 products in this recall →

Same manufacturer · The Compounding Pharmacy of America

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Same hazard · sterility