Agency classClass IIOur severity:Severe FDA (Drugs)·D-1743-2015·Announced 2015-09-23

Testosterone Sterile Pellets Recalled for Lack of Sterility Assurance

The Compounding Pharmacy of America is recalling Testosterone 12.5 mg sterile pellets due to FDA inspection findings of GMP violations that 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. Per the rubric, FDA Class II recalls involving potential sterility failures in sterile products are assigned a score of 4 (Severe) due to the risk of serious injury or infection, even if specific hospitalization reports are not detailed in the provided text.

Plain-English summary

The Compounding Pharmacy of America is recalling Testosterone 12.5 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 specific issue is a lack of assurance of sterility.

The affected product consists of 144 pellets per unit. The recall covers all lots distributed between November 2014 and May 2015. Specific lot codes and dates include 11262014@67, 5/25/2015; 03022015@70, 8/29/2015; 01052015@50, 7/4/2015; 02052015@72, 8/4/2015; and 04302015@53, 10/27/2015. The product was distributed nationwide.

Consumers and healthcare providers should stop using the recalled product and contact the recalling firm or their healthcare provider for instructions on disposal or replacement. The FDA classifies this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product: Testosterone 12.5 mg, Sterile Pellet, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Sterile Pellets
Hazard: lack-of-sterility
gmp-violations
Affected units: 144

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
11262014@67
5/25/2015
03022015@70
8/29/2015
01052015@50
7/4/2015
02052015@72
8/4/2015
04302015@53
10/27/2015

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 →

Critical
FDA Recalls Non-Sterile HCG and Methylcobalamin Injection Vials
FDA (Drugs) · 2018-02-21
Severe
FDA Recalls Morphine and Ropivacaine Compounded Solution Due to Sterility Concerns
FDA (Drugs) · 2015-09-23
Severe
Hydromorphone Solution Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
Severe
Morphine and Bupivacaine Solution Recalled for Sterility Concerns
FDA (Drugs) · 2015-09-23
Severe
Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23

Same hazard · lack of sterility