Axia Pharmaceutical Recalls Betamethasone Injectable Suspension Due to Sterility Concerns
Fusion IV Pharmaceuticals is recalling specific lots of Betamethasone Injectable Suspension because the company cannot guarantee the product is sterile.
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, which corresponds to a Severe severity score under the rubric for potential serious, reversible health consequences.
Plain-English summary
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling specific lots of BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension. The recall was initiated due to a lack of assurance of sterility in the affected products.
The recalled product is a 2 mL single-use vial of 6 mg/mL injectable suspension intended for intramuscular, intra-articular, and intra-tendinous use. The product is preservative-free and requires a prescription. The specific lots affected are 10022019+53004 (expiration date 2/28/2020) and 11252019+53282 (expiration date 6/12/2020).
The product was distributed nationwide in the United States, as well as in Puerto Rico, Barbados, and the Dominican Republic. Patients and healthcare providers should stop using the affected lots and contact their healthcare provider or the manufacturer for further instructions.
The recalled product
- Product
- BETAMETHASONE ACETATE/BETAMETHASONE (PF) Injectable Suspension, Betamethasone Acetate/Betamethasone (PF) CMC [2ML] 6MG/ML INJ SUSP, For IM, IA, IT Use, Shake Well. Preservative Free. Discard Unused Portion, 2 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd.…
- 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 (4)
- Lot #: 10022019+53004
- Exp 2/28/2020
- 11252019+53282
- Exp 6/12/2020
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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