Axia Pharmaceutical Recalls Dexpanthenol Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling Dexpanthenol Injection due to a lack of assurance of sterility. The affected lots were distributed in the U.S., 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 Dexpanthenol Injection, 250 mg/mL, 30 mL multi-dose vials. The recall is being conducted because of a lack of assurance of sterility in the product.
The affected product is identified by NDC 71283-0214-3. The specific lots subject to the recall are 07242019+52740 (expiration date 1/20/2020) and 11202019+53259 (expiration date 5/18/2020). 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 stop using the affected lots of Dexpanthenol Injection. Consumers should contact their healthcare provider or pharmacist for guidance on alternative treatments or further instructions regarding the recalled product.
The recalled product
- Product
- Dexpanthenol Injection, DEXPANTHENOL 250 MG/ML INJECTABLE, For IV, IM Use, Shake Well, 30 mL Multi-dose Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0214-3
- Category
- Drug — Injectable Medication
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 #: 07242019+52740
- Exp 1/20/2020
- 11202019+53259
- Exp 5/18/2020
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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