Agency classClass IIOur severity:Severe FDA (Drugs)·D-1659-2015·Announced 2015-09-23

FDA Recalls Testosterone and Anastrazole Pellets Due to Sterility Concerns

The Compounding Pharmacy of America is recalling Testosterone 200 mg Anastrazole 9 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 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 is recalling Testosterone 200 mg Anastrazole 9 mg Pellets, Sterile. The recall was initiated after an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.

The affected product consists of 94 pellets per unit. The recall covers all lots distributed nationwide between November 2014 and May 2015. Specific lot codes and expiration dates are listed in the recall documentation.

Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for instructions on how to return or dispose of the medication.

The recalled product

Product: Testosterone 200 mg Anastrazole 9 mg Pellet, Sterile, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Compounded Sterile Pellets
Hazard: sterility-failure
gmp-violation
Affected units: 94

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 (11)

All lots distributed between November 2014 and May 2015
01292015@32
7/28/2015
02232015@18
5/20/2015
02272015@31
8/26/2015
03092015@23
9/5/2015
03272015@32
9/23/2015

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