Agency classClass IIOur severity:Severe FDA (Drugs)·D-1651-2015·Announced 2015-09-23

Testosterone Pellets Recalled for Potential Sterility Assurance Issues

The Compounding Pharmacy of America is recalling Testosterone 50 mg Pellets 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 recall is classified as FDA Class II, which corresponds to a 'Severe' severity score under the rubric, particularly given the risk of sterility failure in a sterile injectable product.

Plain-English summary

The Compounding Pharmacy of America, Inc. is recalling Testosterone 50 mg Pellets, Sterile. The recall was initiated because FDA inspections identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.

The affected product consists of 216 pellets per unit. The recall covers all lots distributed nationwide between November 2014 and May 2015. Specific lot codes and distribution dates are listed in the official recall documentation.

Consumers who have purchased this product should contact their healthcare provider or the recalling firm for further instructions on how to proceed.

The recalled product

Product: Testosterone 50 mg Pellet, Sterile, The Compounding Pharmacy of America, Inc., Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable Sterile
Hazard: sterility-failure
gmp-violation
Affected units: 216

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 (19)

All lots distributed between November 2014 and May 2015
12032014@47
6/1/2015
12052014@36
6/3/2015
12192014@33
6/17/2015
01202015@53
7/19/2015
01062015@58
7/5/2015
02122015@40
8/11/2015
03022015@15
8/29/2015
03252015@22
9/21/2015
05082015@6
11/4/2015

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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Same hazard · sterility failure