The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1040-2017·Announced 2017-08-09

Axia Pharmaceutical Recalls Compounded Testosterone Cypionate and Progesterone Vials

Axia Pharmaceutical is recalling 120 vials of compounded Testosterone Cypionate and Progesterone due to CGMP deviations. The product was distributed to one customer in California.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of, or exposure to, the product may cause temporary or medically reversible adverse health consequences. The source cites CGMP deviations without reporting specific injuries or illnesses, aligning with a Moderate severity rating for a voluntary, limited-distribution drug recall.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is voluntarily recalling 120 vials of Testosterone Cypionate + Progesterone, 200 mg/2.5 mg/mL, 10 mL amber glass vials. The recall was initiated on July 12, 2017, and is classified as Class II by the FDA. The reason for the recall is cited as CGMP (Current Good Manufacturing Practice) deviations.

The affected product is identified by Lot # 03022017+44906 with a beyond-use date of August 29, 2017. The recall status is currently terminated. The distribution was limited to one customer located in California.

Consumers and healthcare providers who possess this specific lot of compounded medication should stop using it and contact their healthcare provider or the recalling firm for instructions on return or disposal. The recall was initiated by the firm and notified via letter.

The recalled product

Product
Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass vials, Rx Only, Compounded by AXIA Pharmaceutical, Los Angeles, CA 90025
Manufacturer
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Category
Drug — Compounded Injectable
Hazard
Affected units
120

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 # 03022017+44906
  • BUD 08/29/17

Distribution

Distributed in 1 state:

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