Axia Pharmaceutical Recalls Triamcinolone Diacetate Injectable Suspension Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Triamcinolone Diacetate 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 source text explicitly identifies the agency classification as Class II. According to the severity rubric, an FDA Class II recall involving a sterile injectable product where sterility assurance is lacking is classified as Severe (Score 4) due to the risk of significant injury or infection.
Plain-English summary
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of Triamcinolone Diacetate Injectable Suspension, 80 mg/mL, 10 mL multi-dose vials. The recall is being conducted because the product lacks assurance of sterility.
The affected product is identified by NDC 71283-0634-1. The specific lots subject to recall are 07162019+52686 (expiration date 4/11/2020) and 11062019+53192 (expiration date 8/2/2020). The product was distributed nationwide in the United States, as well as in Puerto Rico, Barbados, and the Dominican Republic.
Healthcare providers and patients should discontinue use of the affected lots and contact their healthcare provider 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 [10ML] CMC 80 MG/ML INJ SUSP, For IM, IA, IT Use, 10 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0634-1
- Category
- Drug — Injectable Sterile
- 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 (4)
- Lot #: 07162019+52686
- Exp 4/11/2020
- 11062019+53192
- Exp 8/2/2020
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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