Drug product
Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14.
D-0331-2021
Product summary
- Event
- Event 87631
- Status
- Terminated
- Classification
- Class III
- Quantity
- 62,040 tubes
- Official record key
drug-enforcement:D-0331-2021
Official wording
Reason: Failed Stability Specifications: product did not meet viscosity results.
Code information: Lot 13269, Exp March 2021
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Failed Stability Specifications