Fluphenazine Decanoate Injection USP 125mg/5mL recall
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.…
Why was Fluphenazine Decanoate Injection USP 125mg/5mL recalled?
Discoloration; Hazy solution found in one vial instead of a clear solution.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot CFD190004, exp. date August 2020
- 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.…
- Recalling firm
- AuroMedics Pharma LLC
- Quantity
- 59,500 vials
- Distribution
- Product was distributed to major wholesalers/distributors who may have further distribute the product throughout the United States.
- Recall date
- December 11, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)