Recalls / Class II
Class IID-0281-2022
Product
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
- Affected lot / code info
- Lot #: 13058, Exp. date 02/2022 and 13768, Exp. date 05/2022
Why it was recalled
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.
Recalling firm
- Firm
- Teligent Pharma, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 105 Lincoln Avenue, Buena, New Jersey 08310
Distribution
- Quantity
- 14,664 glass bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2021-10-12
- FDA classified
- 2021-12-13
- Posted by FDA
- 2021-12-22
- Terminated
- 2024-06-18
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0281-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.