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
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, 2 mL autoinjector, 15-count autoinjectors per carton, Rx only, Meridian Medical Technologies, Columbia, MD 21046; A subsidiary of King Pharmaceuticals, Inc.; NSN 6505-01-274-0951, NDC 11704-600-01.
Affected NDC
11704-0600-01
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 11704-0600 |
10 mg/2mL | Injection Intramuscular |
Meridian Medical Technologies LLC | Rx · CIV |
- Recalling firm
- Meridian Medical Technologies a Pfizer Company
- NDC code
- 11704-600-01
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1369-2012 · 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 Meridian Medical Technologies a Pfizer Company
All 2012 recalls
Class I · High risk
EpiPen Jr. 2-Pak
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
Class I · High risk
EpiPen 2-Pak
Defective Delivery System; reports of the device failing to activate which could result in a patient not receiving medication
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