Agency classClass IIOur severity:High FDA (Drugs)·D-1742-2015·Announced 2015-09-23

Testosterone Pellets Recalled Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Testosterone 100 mg sterile pellets nationwide because FDA inspections found GMP violations affecting 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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (sterility failure) where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

The Compounding Pharmacy of America is recalling 1,222 units of Testosterone 100 mg, Sterile Pellet. The product was distributed nationwide between November 2014 and May 2015. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.

The recall covers all lots distributed during the specified period. The source text does not report any specific illnesses or injuries associated with the use of these pellets. The hazard is described as a lack of assurance of sterility due to the identified manufacturing violations.

Consumers who have purchased or received these specific testosterone pellets should stop using them and contact their healthcare provider or the recalling firm for further instructions on disposal or replacement.

The recalled product

Product: Testosterone 100 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable Steroids
Hazard: sterility-failure
gmp-violation
Affected units: 1,222

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 (20)

All lots distributed between November 2014 and May 2015
01082015@1
7/7/2015
11212014@6
5/20/2015
11212014@8
1242014@51
5/23/2015
11262014@72
5/25/2015
01152015@29
7/14/2015
02112015@12
8/10/2015
12192014@6
6/17/2015
12012014@57
5/30/2015
12022014@33
5/31/2015

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 →

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Morphine and Bupivacaine Solution Recalled for Sterility Concerns
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Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
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Same hazard · sterility failure