Agency classClass IIOur severity:Severe FDA (Drugs)·D-1470-2015·Announced 2015-09-23

Estradiol Pellets Recalled Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Estradiol 22 mg sterile pellets nationwide because FDA inspections found GMP violations that may affect 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 recall is classified as FDA Class II. Per the rubric, FDA Class II recalls involving potential sterility failures in sterile products are categorized as Severe (Score 4), as they represent a significant risk of harm even if specific hospitalization reports are not detailed in the provided text snippet.

Plain-English summary

The Compounding Pharmacy of America, Inc. is recalling Estradiol 22 mg, Sterile Pellets. The recall covers 48-pellet packages distributed nationwide between November 2014 and May 2015. Specific lot codes identified in the recall include 02242015@1 and 05042015@29.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations raise concerns about the assurance of sterility and potentially impact the overall quality of the product.

Consumers who have these products should stop using them and contact their healthcare provider or the recalling firm for instructions on return or disposal. This recall is classified as Class II by the FDA.

The recalled product

Product: Estradiol 22 mg, Sterile Pellet, The Compounding Pharmacy of America, Inc., Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Sterile Pellets
Hazard: sterility-failure
gmp-violation
Affected units: 48

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)

All lots distributed between November 2014 and May 2015
02242015@1
8/23/2015
05042015@29
10/31/2015

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 failure