Agency classClass IIOur severity:Severe FDA (Drugs)·D-1759-2015·Announced 2015-09-23

Testosterone Cypionate Injectable Recalled Due to Sterility Assurance Concerns

The Compounding Pharmacy of America is recalling Testosterone Cypionate 40 mg/ml Injectable due to FDA inspection findings regarding sterility assurance.

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 rating under the rubric, particularly given the risk of sterility failure in an injectable medication.

Plain-English summary

The Compounding Pharmacy of America is recalling Testosterone Cypionate 40 mg/ml Injectable, 7 ml vials. The recall is being conducted because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility.

The recall covers all lots of the product distributed between November 2014 and May 2015. The distribution pattern is listed as nationwide. The specific lot code identified in the recall notice is 04152015@56, with a date of 10/12/2015.

Consumers and healthcare providers should check their inventory for this specific product and lot code. If the product is found, it should be returned to the pharmacy or supplier for credit or replacement. Patients should consult their healthcare provider regarding alternative treatment options if they have been using this product.

The recalled product

Product: Testosterone Cypionate 40 mg/ml Injectable, 5 Sesame, The Compounding Pharmacy of America, Knoxville, TN
Manufacturer: The Compounding Pharmacy of America
Category: Drug — Injectable Steroid
Hazard: sterility-failure
gmp-violation

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 (3)

All lots distributed between November 2014 and May 2015
04152015@56
10/12/2015

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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Methylcobalamin Injectable Recalled for Sterility Assurance Concerns
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Same hazard · sterility failure