Agency classClass IIOur severity:Severe FDA (Drugs)·D-1741-2015·Announced 2015-09-23

Testosterone Pellets Recalled for Lack of Sterility Assurance

The Compounding Pharmacy of America is recalling Testosterone 18 mg sterile pellets due to 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 recall is classified as FDA Class II, and the rubric specifies that FDA Class II recalls involving potential sterility issues in injectable products are rated as Severe (4) due to the risk of serious injury.

Plain-English summary

The Compounding Pharmacy of America is recalling Testosterone 18 mg, Sterile Pellets, 24-pellet packages. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.

The affected lots were distributed nationwide between November 2014 and May 2015. The specific lot codes identified in the recall are 02092015@20 and 8/8/2015.

Consumers who have these products should stop using them and contact the recalling firm or their healthcare provider for instructions on how to return the product or obtain a replacement.

The recalled product

Product: Testosterone 18 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable Steroids
Hazard: sterility
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 (3)

All lots distributed between November 2014 and May 2015
02092015@20
8/8/2015

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