The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0991-2020·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 product lacks assurance of 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a sterile injectable product where sterility assurance is lacking is classified as Severe (Score 4) due to the risk of significant injury or infection.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of Triamcinolone Diacetate Injectable Suspension, 80 mg/mL, 10 mL multi-dose vials. The recall is being conducted because the product lacks assurance of sterility.

The affected product is identified by NDC 71283-0634-1. The specific lots subject to recall are 07162019+52686 (expiration date 4/11/2020) and 11062019+53192 (expiration date 8/2/2020). The product was distributed nationwide in the United States, as well as in Puerto Rico, Barbados, and the Dominican Republic.

Healthcare providers and patients should discontinue use of the affected lots and contact their healthcare provider 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 [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0634-1
Manufacturer
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Category
Drug — Injectable Sterile
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 #: 07162019+52686
  • Exp 4/11/2020
  • 11062019+53192
  • Exp 8/2/2020

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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