The Recall Desk
SevereFDA (Drugs)·D-0987-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Triamcinolone Acetonide Injectable Suspension Due to Sterility Concerns

Axia Pharmaceutical is recalling specific lots of Triamcinolone Acetonide Injectable Suspension because the company cannot guarantee the product is sterile.

What this means for you

Illness, injury, or structural failure has been reported. 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, and the hazard involves a lack of assurance of sterility in an injectable medication, which poses a significant risk of serious injury or infection.

Plain-English summary

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

The affected product is distributed nationwide in the U.S.A., as well as in Puerto Rico, Barbados, and the Dominican Republic. The recall covers five specific lots with expiration dates ranging from February 2020 to May 2020.

Healthcare providers and patients should stop using the affected lots immediately. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions.

The recalled product

Product
Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [2ML] 40MG/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 71283-0635-2
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 (10)

  • Lot #: 08272019+52841
  • Exp 2/22/2020
  • 09242019+52953
  • Exp 3/22/2020
  • 11072019+53198
  • Exp 5/5/2020
  • 11112019+53206
  • Exp 5/9/2020
  • 11122019+53223
  • Exp 5/10/2020

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 →

Related recalls

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

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Same hazard · sterility

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