D-0785-2021 Class III Terminated
FDA drug recall D-0785-2021 was initiated by Teligent Pharma, Inc. on July 29, 2021 and is designated Class III. Reason for recall: Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing. The recall status is terminated (terminated August 15, 2024). Affected quantity: 114,456 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- September 8, 2021
- Initiation Date
- July 29, 2021
- Termination Date
- August 15, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 114,456 tubes
Product Description
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.
Reason for Recall
Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
Lot #: 15378, Exp 3/2023; 14418 EXP 10/2021