Axia Pharmaceutical Recalls Glycerin Injection Due to Sterility Concerns
Axia Pharmaceutical is recalling Glycerin (PF) Injection due to a lack of assurance of sterility. The affected product is distributed nationwide and in several international locations.
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. According to the rubric, FDA Class II recalls with potential for adverse health consequences are categorized as Severe (Score 4), particularly when the hazard involves sterility assurance for an injectable product.
Plain-English summary
Fusion IV Pharmaceuticals, Inc. dba Axia Pharmaceutical is recalling Glycerin (PF) Injection, GLYCERIN 99% INJECTABLE, For IV Use, 10 mL Single-use Vial. The recall is being conducted because of a lack of assurance of sterility. The affected product is identified by NDC 71283-0464-1 and includes Lot # 08142019+52805 with an expiration date of 2/10/2020.
The product was distributed in the U.S.A. nationwide, as well as in Puerto Rico, Barbados, and the Dominican Republic. The source text does not specify the number of units affected or report any illnesses or injuries associated with the use of this product.
Healthcare providers and consumers should stop using the affected product and contact the manufacturer or their local health authority 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
- Glycerin (PF) Injection,GLYCERIN 99% INJECTABLE, For IV Use,10 mL Single-use Vial, Rx only, Axia Pharmaceutical 1990 Westwood Blvd. Ste 135, Los Angeles, CA 90025; NDC 71283-0464-1
- Category
- Drug — Injectable
- 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 (2)
- Lot #: 08142019+52805
- Exp 2/10/2020
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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