Why it was recalled
Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
Product description
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, Inc., Lake Forest, IL 60045, NDC 0409-8060-29
Lot numbers, UPCs & expiration codes
Lot 34-531-DK, Exp 10/01/2015
Where it was sold
Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0054-2016
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Sep 29, 2015
- FDA report date
- Oct 28, 2015
- Quantity
- 24,100 Syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Hospira Inc.
Original FDA data
Every field from FDA enforcement report D-0054-2016, exactly as published.
Show all FDA fields
- City
- Lake Forest
- State
- IL
- Status
- Ongoing
- Country
- United States
- Event ID
- 72432
- Address
- 275 N Field Dr
- Code information
- Lot 34-531-DK, Exp 10/01/2015
- Postal code
- 60045-2579
- Report date
- Oct 28, 2015
- Product type
- Drugs
- Recall number
- D-0054-2016
- Classification
- Class III
- Recalling firm
- Hospira Inc.
- Product quantity
- 24,100 Syringes
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of Specification(OOS) results for degradation product of etomidate was confirmed during stability testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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, Inc., Lake Forest, IL 60045, NDC 0409-8060-29
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 29, 2015
- Initial firm notification
- Letter
- Center classification date
- Oct 21, 2015