Axia Pharmaceutical Recalls Triamcinolone Diacetate Injectable Suspension Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Triamcinolone Diacetate Injectable Suspension because the company cannot assure the sterility of the product.
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 rubric specifies that FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated as Severe. While the source does not explicitly report injuries, the 'Lack of Assurance of Sterility' for an injectable drug represents a significant risk of serious harm (sepsis, infection) that aligns with the 'Severe' criteria for high-risk medical products where the hazard is not merely theoretical but a direct failure of a critical safety attribute (sterility).
Plain-English summary
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of Triamcinolone Diacetate Injectable Suspension, 40 mg/mL, 2 mL single-use vials. The recall is being conducted because the company lacks assurance of the sterility of the affected product.
The affected lots are 08272019+52845 (expiration date 2/23/2020) and 09252019+52965 (expiration date 3/23/2020). The product was 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 their pharmacist or the recalling firm 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 (PF) [2ML] CMC 40 MG/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 71283-0628-2
- Category
- Drug — Injectable Steroid
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 #: 08272019+52845
- Exp 2/23/2020
- 09252019+52965
- Exp 3/23/2020
Distribution
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.
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