Amidate recall: Impurity Out of Spec
Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira…
Why was Amidate recalled?
Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA 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 34-531-DK, Exp 10/01/2015
- Product
- Amidate (Etomidate Injection, USP), 40 mg/20 mL (2 mg/mL), LifeShield, 20 mL, Glass Abboject Syringe with male luer lock adapter, Rx only, Hospira…
- Recalling firm
- Hospira Inc.
- Quantity
- 24,100 Syringes
- Distribution
- Nationwide
- Recall date
- October 28, 2015
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)