Agency classClass IIOur severity:Severe FDA (Drugs)·D-1652-2015·Announced 2015-09-23

Testosterone Pellets Recalled Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Testosterone 62.5 mg Pellets because an FDA inspection 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 source text explicitly identifies the agency classification as Class II. According to the rubric, an FDA Class II recall involving a sterile product with GMP violations impacting sterility falls under the 'Severe' category (Score 4), as it represents a significant risk to product integrity and patient safety.

Plain-English summary

The Compounding Pharmacy of America is recalling Testosterone 62.5 mg Pellets, Sterile. The recall involves 24-pellet packages distributed nationwide between November 2014 and May 2015. The specific lot codes are 05062015@31 and 11/2/2015.

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. The agency has classified this as a Class II recall.

Consumers who have these specific lots of Testosterone 62.5 mg Pellets should stop using them and contact their healthcare provider or the recalling firm for instructions on return or disposal.

The recalled product

Product: Testosterone 62.5 mg Pellet, Sterile, 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: 24

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 05062015@31
11/2/2015

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