Drug product
Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 patch each/ 30 Patches/Carton (NDC 0591-3525-30)
D-0857-2018
Product summary
- Event
- Event 80004
- Status
- Terminated
- Classification
- Class III
- Quantity
- 30,382 patches
- Official record key
drug-enforcement:D-0857-2018
Official wording
Reason: Failed Stability Specifications
Code information: Carton Lot Number:1147020B Patch (Envelope) Lot Number: 1147020
Distribution pattern: United States
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications