Drug product
Lidocaine 4% Syr (PF) Rx, 1 mL packaged in 3 mL syringes, Vann Healthcare Pharmacy, 1220 N Race Street, Glasgow, KY 42141
D-0311-2015
Product summary
- Event
- Event 69633
- Status
- Terminated
- Classification
- Class II
- Quantity
- 900 syringes
- Official record key
drug-enforcement:D-0311-2015
Official wording
Reason: 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.
Code information: Lot #s: 06174A, 07214B, and 08154A.
Distribution pattern: KY
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility