The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0990-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Triamcinolone Diacetate Injectable Suspension Due to Sterility Concerns

Axia Pharmaceutical is recalling specific lots of Triamcinolone Diacetate Injectable Suspension because the company cannot assure the sterility of the product.

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 rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While the source does not explicitly report injuries, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of serious harm (sepsis, infection) that aligns with the 'Severe' criteria for high-risk medical products where the hazard is not merely theoretical but a direct failure of a critical safety attribute (sterility).

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 2 mL single-use vials. The recall is being conducted because the company lacks assurance of the sterility of the affected product.

The affected lots are 08272019+52845 (expiration date 2/23/2020) and 09252019+52965 (expiration date 3/23/2020). The product was distributed nationwide in the U.S.A., as well as in Puerto Rico, Barbados, and the Dominican Republic.

Healthcare providers and patients should stop using the affected lots and contact their pharmacist or the recalling firm for further instructions. The FDA has classified 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
Triamcinolone Diacetate Injectable Suspension, TRIAMCINOLONE DIACETATE (PF) [2ML] CMC 40 MG/ML INJ SUSP, For IM, IA, IT Use, 2 mL Single Use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0628-2
Manufacturer
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Category
Drug — Injectable Steroid
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 (4)

  • Lot #: 08272019+52845
  • Exp 2/23/2020
  • 09252019+52965
  • Exp 3/23/2020

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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Same manufacturer · Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical

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