Agency classClass IIOur severity:Severe FDA (Drugs)·D-1465-2015·Announced 2015-09-23

FDA Recalls Estradiol Pellets Due to Sterility Concerns

The Compounding Pharmacy of America is recalling Estradiol 100 mg sterile pellets nationwide because FDA inspections found GMP violations that may impact 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, and the hazard involves a lack of assurance of sterility in a sterile product, which poses a significant risk of infection or serious injury.

Plain-English summary

The Compounding Pharmacy of America is recalling Estradiol 100 mg, Sterile Pellets. The recall involves 98 pellets distributed nationwide between November 2014 and May 2015. Specific lot codes include 01122015@36, 04022015@40, and 05072015@56.

The recall was initiated due to a lack of assurance of sterility. FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.

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

The recalled product

Product: Estradiol 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Compounded Sterile Product
Hazard: sterility-failure
gmp-violation
Affected units: 98

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 (7)

All lots distributed between November 2014 and May 2015
01122015@36
7/11/2015
04022015@40
9/29/2015
05072015@56
11/3/2015

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 failure