CLASS II Drug recall · Reported 20 Jun 2012 · FDA Enforcement Report
Diazepam Injection, USP, 10 mg Automatic, Autoinjector recalled
Meridian Medical Technologies a Pfizer is recalling Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL, distributed nationwide in the US. The recall was initiated on 6 Jun 2012 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1369-2012
- FDA event ID
- 62015
- Recalling firm
- Meridian Medical Technologies a Pfizer, Saint Louis, MO
- Brand
- Diazepam
- Manufacturer
- Meridian Medical Technologies LLC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Jun 2012
- FDA classified
- 11 Jun 2012
- Reported
- 20 Jun 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Potency & Assay
- Drug class
- Anxiety & Sleep Medication
Timeline
| 6 Jun 2012 | Recall initiated by company | |
| 11 Jun 2012 | Classified by FDA | +5 days |
| 20 Jun 2012 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide, military, Italy, Singapore, Sweden, and Canada.
Questions about this recall
Is Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL recalled?
Yes. Meridian Medical Technologies a Pfizer recalled Diazepam Injection, USP, 10 mg Automatic, Autoinjector for Buddy Use, 5 mg/mL on 6 Jun 2012. The recall is Class II and its status is Terminated. Recall number D-1369-2012.
Why was it recalled?
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Which lots are affected?
Lot #: 8D1082, Exp 01/13; 8D1151, Exp 03/13
Where was it sold?
Nationwide, military, Italy, Singapore, Sweden, and Canada.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Meridian Medical Technologies a Pfizer
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | EpiPen Jr. 2-Pak (Epinephrine) Auto-Injectors 15 mg recalledEpipen | Meridian Medical Technologies a Pfizer | Other | Nationwide |
| Drug | CLASS I | EpiPen 2-Pak (Epinephrine) Auto-Injectors 3 mg recalledEpipen | Meridian Medical Technologies a Pfizer | Other | Nationwide |
Other Diazepam recalls
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diazepam Oral Solution (Concentrate), 25 mg recalled by Lannett Company | Lannett Company | Potency & Assay | Nationwide |
| Drug | CLASS III | Diazepam Rectal Gel, 5 mg, Twin Pack that Contains recalledDiazepam | Valeant Pharmaceuticals North America | Other | Nationwide |
| Drug | CLASS II | Diazepam Injection USP 10mg/ (5 mg/mL recalled by HospiraDiazepam | Hospira | Particulate Matter | Nationwide |
| Drug | CLASS II | Diazepam Injection, USP, 5 mg/mL recalled by HospiraDiazepam | Hospira | Sterility | Nationwide |
| Drug | CLASS II | Diazepam Injection, USP 5 mg/mL, Multiple-dose fliptop vial recalledDiazepam | Hospira | Sterility | Nationwide |