Why it was recalled
Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.
Product description
Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
Lot numbers, UPCs & expiration codes
Lot #s: 06174A, 07214B, and 08154A.
Where it was sold
KY
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-0311-2015
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Oct 14, 2014
- FDA report date
- Dec 31, 2014
- Quantity
- 900 syringes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Vann Healthcare Services Inc
Original FDA data
Every field from FDA enforcement report D-0311-2015, exactly as published.
Show all FDA fields
- City
- Glasgow
- State
- KY
- Status
- Terminated
- Country
- United States
- Event ID
- 69633
- Address
- 1220 N Race St
- Code information
- Lot #s: 06174A, 07214B, and 08154A.
- Postal code
- 42141-3462
- Report date
- Dec 31, 2014
- Product type
- Drugs
- Recall number
- D-0311-2015
- Classification
- Class II
- Recalling firm
- Vann Healthcare Services Inc
- Product quantity
- 900 syringes
- Termination date
- Jul 1, 2015
- Reason for recall
- Lack of Assurance of Sterility: A recent FDA inspection of Vann Healthcare Services facility revealed deficiencies that raise concerns about the pharmacy's ability to consistently assure sterility of their products.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
- Distribution pattern
- KY
- Recall initiation date
- Oct 14, 2014
- Initial firm notification
- Letter
- Center classification date
- Dec 19, 2014