Recalls / Class I
Class ID-0800-2021
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% , 50 mL glass bottles, Rx Only, Teligent Pharma Inc. Buena, New Jersey 08310, NDC 52565-009-50.
- Affected lot / code info
- Lot #:14218, Exp. Date 08/2022
Why it was recalled
Superpotent Drug
Recalling firm
- Firm
- Teligent Pharma, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 105 Lincoln Avenue, N/A, Buena, New Jersey 08310
Distribution
- Quantity
- 32,544 glass bottles
- Distribution pattern
- Nationwide within the United States and Canada
Timeline
- Recall initiated
- 2021-08-03
- FDA classified
- 2021-09-15
- Posted by FDA
- 2021-09-22
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0800-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.