Why it was recalled
Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 8D1082, Exp 01/13; 8D1151, Exp 03/13
Where it was sold
Nationwide, military, Italy, Singapore, Sweden, and Canada.
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-1369-2012
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 6, 2012
- FDA report date
- Jun 20, 2012
- Quantity
- 83,400 autoinjectors
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Meridian Medical Technologies a Pfizer Company
Original FDA data
Every field from FDA enforcement report D-1369-2012, exactly as published.
Show all FDA fields
- City
- Saint Louis
- State
- MO
- Status
- Terminated
- Country
- United States
- Event ID
- 62015
- Address
- 1945 Craig Rd
- Code information
- Lot #: 8D1082, Exp 01/13; 8D1151, Exp 03/13
- Postal code
- 63146-4105
- Report date
- Jun 20, 2012
- Product type
- Drugs
- Recall number
- D-1369-2012
- Classification
- Class II
- Recalling firm
- Meridian Medical Technologies a Pfizer Company
- Product quantity
- 83,400 autoinjectors
- Termination date
- Aug 5, 2013
- Reason for recall
- Impurities/Degradation Products: High Out of Specification levels for carbostyril, a known degradation product of diazepam.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Nationwide, military, Italy, Singapore, Sweden, and Canada.
- Recall initiation date
- Jun 6, 2012
- Initial firm notification
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Center classification date
- Jun 11, 2012