The Recall Desk
Agency classClass IIOur severity:SevereFDA (Drugs)·D-0943-2020·Announced 2020-03-11

Axia Pharmaceutical Recalls Betamethasone Injectable Suspension Due to Sterility Concerns

Axia Pharmaceutical is recalling Betamethasone Acetate/Betamethasone Injectable Suspension due to a lack of assurance of sterility. The product was distributed nationwide and in Puerto Rico, Barbados, and the Dominican Republic.

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 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 Betamethasone Acetate/Betamethasone (PF) Injectable Suspension, 7mg/mL, 10 mL multi-dose vials. The recall was initiated because of a lack of assurance of sterility in the product.

The affected product is a prescription-only injectable suspension intended for intramuscular and intra-articular use. It was distributed in the United States nationwide, as well as in Puerto Rico, Barbados, and the Dominican Republic. The recall covers multiple lots with expiration dates ranging from February 2020 to July 2020.

Healthcare providers and patients should stop using the recalled product. Consumers should contact their healthcare provider for guidance on alternative treatments or further instructions regarding the recalled medication.

The recalled product

Product
BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [10ML] 7MG/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…
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 (20)

  • Lot #: 07092019+52610
  • Exp 2/6/2020
  • 07232019+52734
  • Exp 2/19/2020
  • 08282019+52853
  • 09042019+52878
  • 09102019+52903
  • Exp 3/2/2020
  • 09182019+52929
  • Exp 4/17/2020
  • 10092019+53082
  • Exp 2/28/2020
  • 10152019+53124
  • Exp 5/4/2020
  • 10222019+53142
  • 10292019+53160
  • 11052019+53186
  • 11202019+53257
  • Exp 6/19/2020
  • 11212019+53270

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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Same hazard · sterility

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