Drug product
Lidocaine 4% Urethral Gel
D-1098-2014
Product summary
- Event
- Event 66856
- Status
- Terminated
- Classification
- Class II
- Quantity
- 104 syringes
- Official record key
drug-enforcement:D-1098-2014
Official wording
Reason: Lack of Sterility Assurance: All lots of sterile products compounded by the pharmacy that are not expired due to concerns associated with quality control procedures that present a potential risk to sterility assurance that were observed during a recent FDA inspection.
Code information: Lot# 101213, Exp. 04/14 Lot# 09202013, Exp. 03/14 Lot# 08272013, Exp. 02/14 Lot# 08022013, Exp. 01/14
Distribution pattern: NC
Derived failure modes
-
Sterility assurance
Lack of Sterility