AuroMedics Recalls Fluphenazine Decanoate Injection Due to Discoloration
AuroMedics Pharma LLC is recalling Fluphenazine Decanoate Injection due to discoloration and haziness found in one vial.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a physical quality defect (discoloration/haziness) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
AuroMedics Pharma LLC is recalling 59,500 vials of Fluphenazine Decanoate Injection USP 125mg/5mL. The product is a prescription-only medication intended for intramuscular or subcutaneous use. The specific lot affected is CFD190004, with an expiration date of August 2020.
The recall was initiated because a discolored, hazy solution was found in one vial, whereas the solution should be clear. The product was manufactured in India for AuroMedics Pharma, LLC, located in E. Windsor, NJ.
The product was distributed to major wholesalers and distributors who may have further distributed it throughout the United States. Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- Fluphenazine Decanoate Injection USP 125mg/5mL, (5 mL Multiple Dose Vial), Rx only, For IM or SC Use, Mfd in India for: AuroMedics Pharma, LLC, E. Windsor, NJ
- Manufacturer
- AuroMedics Pharma LLC
- Category
- Drug — Injection
- Affected units
- 59,500
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 CFD190004
- exp. date August 2020
Distribution
Distribution scope not specified by the agency.
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