Drug product
Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.
D-0785-2021
Product summary
- Event
- Event 88382
- Status
- Terminated
- Classification
- Class III
- Quantity
- 114,456 tubes
- Official record key
drug-enforcement:D-0785-2021
Official wording
Reason: Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
Code information: Lot #: 15378, Exp 3/2023; 14418 EXP 10/2021
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Potency or specification failure
does not meet specification