Dexamethasone Sodium Phosphate Preservative Free recall: Sterility Concern
Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs…
Why was Dexamethasone Sodium Phosphate Preservative Free 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
- Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24mg/mL, 1mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs…
- Recalling firm
- Premier Pharmacy Labs Inc
- Quantity
- 86 syringes
- Distribution
- Nationwide in the USA
- Recall date
- July 3, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)