Class II · Moderate risk
Diazepam Oral Solution
Failed Impurities/Degradation Specifications: Out of specification results for related substances.
Diazepam Injection
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, HOSPIRA, INC. LAKE FOREST, IL 60045 USA, NDC 0409-3213-12
Affected NDC
0409-3213-12
Compare with the code on your package — it is the most precise check available.
Drug: Diazepam
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Diazepam NDC 00409-3213 |
5 mg/mL | Injection, Solution Intramuscular|intravenous |
Hospira, Inc. | Rx · CIV |
- Recalling firm
- Hospira Inc.
- NDC code
- 0409-3213-12
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-501-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Diazepam recalls
See all
Class II · Moderate risk
diazePAM 5 MG/ML INJECTION SOLUTION
Lack of Assurance of Sterility
Class III · Low risk
Diazepam Rectal Gel
Labeling: Incorrect or Missing Lot and/or Exp Date: Product distributed without a lot number or expiration date on the outer carton.
Class II · Moderate risk
Diazepam Injection USP 10mg/2mL
Crystallization: Product contains particulate identified to be crystallized active ingredient.
Class II · Moderate risk
Diazepam 5 mg/mL injectable packaged in an amber glass injectable vial
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Other recalls by Hospira Inc.
All 2013 recalls
Class I · High risk
Infant 25% DEXTROSE Injection
Presence of Particulate Matter: human hair found within an internal sample syringe.
Class II · Moderate risk
Fentanyl Citrate Injection
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Class II · Moderate risk
DOBUTamine Injection
Discoloration: Firm received complaints of product discoloration and particulates.
Class III · Low risk
5% Lidocaine HCL and 7.5% Dextrose Injection
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
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