Recalls / Class III
Class IIID-0331-2021
Product
Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent Pharma Inc., Buena, New Jersey, 08310, NDC 52565-008-14.
- Affected lot / code info
- Lot 13269, Exp March 2021
Why it was recalled
Failed Stability Specifications: product did not meet viscosity results.
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
- 62,040 tubes
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2021-03-29
- FDA classified
- 2021-04-12
- Posted by FDA
- 2021-04-21
- Terminated
- 2024-07-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0331-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.