Class II
Terminated
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
- Company
- Teligent Pharma, Inc.
- Recall Initiated
- October 12, 2021
- Posted
- December 22, 2021
- Recall Number
- D-0281-2022
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 14,664 glass bottles
- Firm Location
- Buena, NJ, United States
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
Nationwide within the United States
Lot / Code Info
Lot #: 13058, Exp. date 02/2022 and 13768, Exp. date 05/2022
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