Agency classClass IIOur severity:Severe FDA (Drugs)·D-1752-2015·Announced 2015-09-23

Compounded Testosterone and Estradiol Injection Recalled for Sterility Concerns

The Compounding Pharmacy of America is recalling Testosterone Bi-Blend and Estradiol Valerate injections due to FDA inspection findings regarding sterility assurance.

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. Per the rubric, FDA Class II recalls involving potential sterility failures in injectable products are classified as Severe (Score 4) due to the risk of serious injury from non-sterile administration.

Plain-English summary

The Compounding Pharmacy of America is recalling Testosterone Bi-Blend 15 mg/ml + Estradiol Valerate 5 mg/ml Injection, Multi-Dose Vial. The product is sterile, room temperature, and available in 12 ml vials. The recall covers all lots distributed between November 2014 and May 2015, including lot 03252015@48. Distribution was nationwide.

The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, creating a lack of assurance that the product is sterile.

Consumers and healthcare providers who have this product should stop using it and contact the recalling firm or their healthcare provider for instructions on return or disposal.

The recalled product

Product: Testosterone Bi-Blend 15 mg/ml +Estradiol Valerate 5 mg/ml Injection, Multi-Dose Vial,Sterile, Room Temperature, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Compounded Injectable
Hazard: sterility-failure
gmp-violation

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)

All lots distributed between November 2014 and May 2015 03252015@48
9/21/15

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