Status
Terminated
Drug Enforcement D-417-2013
Lack of Assurance of Sterility; reports of adverse events after injection
Classification
Class II
Report Date
May 22, 2013
Termination Date
October 19, 2016
Product Information
- Product description
- Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244
- Product quantity
- 32 vials
- Reason for recall
- Lack of Assurance of Sterility; reports of adverse events after injection
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- FL, MO, UT, and WA.
Location & Firm
- Recalling firm
- NuVision Pharmacy, Inc.
- Address
-
4001 McEwen Road, Suite 110
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-417-2013
- Event ID
- 64722
- Recall initiation date
- March 28, 2013
- Center classification date
- May 16, 2013
- Code info
- Lot Number N01232013@4, Do Not Use Beyond Date of January 1, 2014
- More code info
- —