Agency classClass IIOur severity:Severe FDA (Drugs)·D-1745-2015·Announced 2015-09-23

Testosterone Pellets Recalled for Lack of Sterility Assurance

The Compounding Pharmacy of America is recalling Testosterone 200 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 with potential for serious harm (such as sterility failures in injectable/implantable drugs) are rated as Severe.

Plain-English summary

The Compounding Pharmacy of America is recalling 510 Testosterone 200 mg sterile pellets. The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the quality and sterility of the product.

The affected lots were distributed nationwide between November 2014 and May 2015. The recall covers specific lot codes and expiration dates listed in the official notice, including lots distributed as late as October 2015.

Consumers who have these specific lots of Testosterone 200 mg sterile 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 200 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Testosterone Pellets
Hazard: sterility-failure
gmp-violation
Affected units: 510

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
12122014@8
6/10/2015
12042014@47
6/2/2015
01122015@54
7/11/2015
04142015@82
10/11/2015
01072015@32
7/6/2015
01192015@17
7/18/2015
02042015@43
8/3/2015
02232015@35
8/22/2015
02272015@30
8/26/2015
02272015@19

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