D-0331-2021 Class III Terminated
FDA drug recall D-0331-2021 was initiated by Teligent Pharma, Inc. on March 29, 2021 and is designated Class III. Reason for recall: Failed Stability Specifications: product did not meet viscosity results. The recall status is terminated (terminated July 3, 2024). Affected quantity: 62,040 tubes.
Recall Details
- Product Type
- Drugs
- Report Date
- April 21, 2021
- Initiation Date
- March 29, 2021
- Termination Date
- July 3, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 62,040 tubes
Product Description
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.
Reason for Recall
Failed Stability Specifications: product did not meet viscosity results.
Distribution Pattern
Nationwide in the USA
Code Information
Lot 13269, Exp March 2021