Why it was recalled
Lack of Assurance of Sterility; reports of adverse events after injection
Product description
Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244
Lot numbers, UPCs & expiration codes
Lot Number N01232013@4, Do Not Use Beyond Date of January 1, 2014
Where it was sold
FL, MO, UT, and WA.
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-417-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 28, 2013
- FDA report date
- May 22, 2013
- Quantity
- 32 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- NuVision Pharmacy, Inc.
Original FDA data
Every field from FDA enforcement report D-417-2013, exactly as published.
Show all FDA fields
- City
- Dallas
- State
- TX
- Status
- Terminated
- Country
- United States
- Event ID
- 64722
- Address
- 4001 McEwen Road
- Address (line 2)
- Suite 110
- Code information
- Lot Number N01232013@4, Do Not Use Beyond Date of January 1, 2014
- Postal code
- 75244
- Report date
- May 22, 2013
- Product type
- Drugs
- Recall number
- D-417-2013
- Classification
- Class II
- Recalling firm
- NuVision Pharmacy, Inc.
- Product quantity
- 32 vials
- Termination date
- Oct 19, 2016
- Reason for recall
- Lack of Assurance of Sterility; reports of adverse events after injection
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Methylcobalamin (Buffered) Injection,1 mg/mL, 30 mL vial, Stock# 11126, Preservative Free, Compounded by NuVision Pharmacy, Inc., Dallas, TX 75244
- Distribution pattern
- FL, MO, UT, and WA.
- Recall initiation date
- Mar 28, 2013
- Initial firm notification
- Letter
- Center classification date
- May 16, 2013