Recalls / Class I
Class ID-0280-2022
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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
- Affected lot / code info
- Lot #: 13262, Exp. 03/2022; 14217, Exp. 08/2022
Why it was recalled
Superpotent Drug
Recalling firm
- Firm
- Teligent Pharma, Inc.
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 105 Lincoln Avenue, Buena, New Jersey 08310
Distribution
- Quantity
- 52,104 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-0280-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.