Agency classClass IIOur severity:Severe FDA (Drugs)·D-1464-2015·Announced 2015-09-23

Estradiol Pellets Recalled for Lack of Sterility Assurance

The Compounding Pharmacy of America is recalling Estradiol 10 mg Sterile Pellets nationwide due to FDA inspection findings of GMP violations impacting 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 significant quality/sterility issues that could lead to serious injury are classified as Severe.

Plain-English summary

The Compounding Pharmacy of America is recalling Estradiol 10 mg Sterile Pellets. The recall covers 212 pellets distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the recall documentation.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the quality and sterility of the product, resulting in a lack of assurance of sterility.

Consumers who have purchased these specific lots of Estradiol 10 mg Sterile Pellets should stop using them and contact their healthcare provider or the recalling firm for instructions on how to return the product.

The recalled product

Product: Estradiol 10 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: 212

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 (17)

All lots distributed between November 2014 and May 2015
12082014@56
6/6/2015
01222015@28
7/21/2015
01062015@73
7/5/2015
03022015@55
8/29/2015
03242015@94
9/20/2015
04222015@32
10/19/2015
04222015@47
04222015@49
04302015@54
10/27/2015

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

See all →

Critical
FDA Recalls Non-Sterile HCG and Methylcobalamin Injection Vials
FDA (Drugs) · 2018-02-21
Severe
FDA Recalls Morphine and Ropivacaine Compounded Solution Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
Severe
Hydromorphone Solution Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
Severe
Morphine and Bupivacaine Solution Recalled for Sterility Concerns
FDA (Drugs) · 2015-09-23
Severe
Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23

Same hazard · sterility