FDA Recall D-0280-2022
Teligent Pharma, Inc. · Buena, NJ
Class I — life-threatening Terminated 980 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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
Reason for recall
Superpotent Drug
Recall record
- Recall number
D-0280-2022- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide within the United States
- Recall initiated
- 2021-10-12
- Classified by FDA Center
- 2021-12-13
- FDA published
- 2021-12-22
- Terminated
- 2024-06-18
- Recalling firm
- Teligent Pharma, Inc.
- Firm location
- Buena, NJ