Axia Pharmaceutical Recalls Triamcinolone Acetonide Injectable Suspension Due to Sterility Concerns
Axia Pharmaceutical is recalling specific lots of Triamcinolone Acetonide Injectable Suspension because the company cannot ensure the product is sterile.
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, and the hazard involves a lack of assurance of sterility in an injectable product, which poses a significant risk of serious injury or death if contaminated.
Plain-English summary
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of Triamcinolone Acetonide (PF) Injectable Suspension. The recall is being conducted because the company lacks assurance of the product's sterility.
The affected product is a 2 mL single-use vial of 50 mg/mL injectable suspension intended for intramuscular, intra-articular, and intra-tissue use. The specific lots involved are 06132019+52446 (expiration date 7/17/2020) and 11142019+53240 (expiration date 12/18/2020). The NDC number for the product is 71283-0633-1.
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 stop using the affected lots and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- Triamcinolone Acetonide (PF) Injectable Suspension, TRIAMCINOLONE ACETONIDE (PF) [10ML] 50MG/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 # 71283-0633-1
- 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 #: 06132019+52446
- Exp 7/17/2020
- 11142019+53240
- Exp 12/18/2020
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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