D-0281-2022 Class II Terminated
FDA drug recall D-0281-2022 was initiated by Teligent Pharma, Inc. on October 12, 2021 and is designated Class II. Reason for recall: CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent. The recall status is terminated (terminated June 18, 2024). Affected quantity: 14,664 glass bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- December 22, 2021
- Initiation Date
- October 12, 2021
- Termination Date
- June 18, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,664 glass bottles
Product Description
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottles, Rx Only, Teligent Pharma Inc., Buena, NJ 08310, NDC 52565-009-50
Reason for Recall
CGMP Deviations: Lots recalled because they were manufactured at the same facility using the same components as the products that had cracked seals in caps that were found to be superpotent.
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 13058, Exp. date 02/2022 and 13768, Exp. date 05/2022