The Recall Desk
SevereFDA (Drugs)·D-0971-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Methylprednisolone Acetate Injectable Suspension Due to Sterility Concerns

Axia Pharmaceutical is recalling specific lots of Methylprednisolone Acetate Injectable Suspension because the product lacks assurance of sterility.

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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or hospitalization are rated Severe (4). While specific injury reports are not detailed in the text, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of serious adverse health consequences, aligning with the Severe criteria for Class II recalls with potential for significant harm.

Plain-English summary

Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of Methylprednisolone Acetate Injectable Suspension, 100 mg/mL, 10 mL multi-dose vials. The recall was initiated due to a lack of assurance of sterility in the affected products.

The affected lots are 06122019+52423 (Exp 7/9/2020), 06122019+52420 (Exp 7/9/2020), and 07182019+52703 (Exp 8/14/2020). These products were 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 the manufacturer or their local FDA office 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
Methylprednisolone Acetate Injectable Suspension, METHYLPREDNISOLONE ACETATE [10ML] CMC 100 MG/ML INJ SUSP, For IM, IA Use, Shake Well, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0619-1
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 (5)

  • Lot #: 06122019+52423
  • Exp 7/9/2020
  • 06122019+52420
  • 07182019+52703
  • Exp 8/14/2020

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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