The Recall Desk
HighFDA (Drugs)·D-0986-2020·Announced 2020-03-11

Recall of Triamcinolone Acetonide/Bupivacaine Injectable Suspension Due to Sterility Concerns

FDA recalls Triamcinolone Acetonide/Bupivacaine Injectable Suspension due to lack of sterility assurance. The drug was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

What this means for you

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: FDA Class II recall for an injectable drug with lack of sterility assurance; no reported illnesses or injuries, fitting the rubric's 'risk-of-harm products where injury has not yet been reported' criterion for High severity.

Plain-English summary

Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension is being recalled by Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical. The affected lot is 05292019+52328 with an expiration date of 2/13/2020. The product is a 10 mL multi-dose vial for intramuscular or intra-articular use.

The recall is due to a lack of assurance of sterility. The U.S. Food and Drug Administration has classified this as a Class II recall, indicating the product may pose a risk of adverse health consequences. Non-sterile injectable medication could potentially cause infection or other complications.

The product was distributed throughout the United States, Puerto Rico, Barbados, and the Dominican Republic. Healthcare providers and patients who have the affected lot should discontinue use immediately and return unused product to the place of purchase or contact the manufacturer.

The recalled product

Product
Triamcinolone Acetonide/Bupivacaine Hydrochloride Injectable Suspension, TRIAMCINOLONE ACET/BUPIVACAINE HCL [10ML] 40MG/5MG/ML INJ SUSP, For IM, IA Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0632-1
Manufacturer
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical
Category
Drug
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 #: 05292019+52328
  • Exp 2/13/2020

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 failure

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