D-0311-2015 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- December 31, 2014
- Initiation Date
- October 14, 2014
- Termination Date
- July 1, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 900 syringes
Product Description
Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
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.
Distribution Pattern
KY
Code Information
Lot #s: 06174A, 07214B, and 08154A.