The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0984-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Testosterone Cypionate Injection Due to Sterility Concerns

Axia Pharmaceutical is recalling Testosterone Cypionate Injection because the product lacks assurance of sterility. The recall covers specific lots distributed in the U.S., Puerto Rico, Barbados, and the Dominican Republic.

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 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II. The hazard is a lack of assurance of sterility in an injectable drug, which poses a risk of harm, but the source text does not report any illnesses or injuries, fitting the criteria for a High severity score.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling Testosterone Cypionate Injection, 200 mg/mL, 1 mL multi-dose vials. The recall is being conducted because the product lacks assurance of sterility. The affected product is identified by NDC 71283-0530-2 and Lot # 03062019+51706, with an expiration date of 6/28/2020.

The recalled product was distributed nationwide in the United States, as well as in Puerto Rico, Barbados, and the Dominican Republic. The source text does not specify the exact number of units recalled or report any illnesses or injuries associated with the product.

Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions. The recall is classified as FDA Class II, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.

The recalled product

Product
Testosterone Cypionate Injection, TESTOSTERONE CYP IN GRAPESEED OIL [1ML] 200 MG/ML INJECTABLE, For IM Use, 1 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0530-2
Manufacturer
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Category
Drug — Injectable
Hazard

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 (2)

  • Lot #: 03062019+51706
  • Exp 6/28/2020

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 63 recalled by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical 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 63 products in this recall →

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