Recalls / Class III
Class IIID-0785-2021
Product
Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a laminat tube, Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-008-14.
- Affected lot / code info
- Lot #: 15378, Exp 3/2023; 14418 EXP 10/2021
Why it was recalled
Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
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
- 114,456 tubes
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2021-07-29
- FDA classified
- 2021-08-31
- Posted by FDA
- 2021-09-08
- Terminated
- 2024-08-15
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0785-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.