Droperidol Injectable Sterile Solution recall: Sterility Concern
Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way…
Why was Droperidol Injectable Sterile Solution recalled?
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
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?
All lots remaining within expiry.
- Product
- Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way…
- Recalling firm
- Premier Pharmacy Labs Inc
- Quantity
- 2315 syringes
- Distribution
- Nationwide in the USA
- Recall date
- July 3, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)