Why it was recalled
Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
Product description
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.
Lot numbers, UPCs & expiration codes
Lot #: 15378, Exp 3/2023; 14418 EXP 10/2021
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0785-2021
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 29, 2021
- FDA report date
- Sep 8, 2021
- Quantity
- 114,456 tubes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teligent Pharma, Inc.
Original FDA data
Every field from FDA enforcement report D-0785-2021, exactly as published.
Show all FDA fields
- City
- Buena
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 88382
- Address
- 105 Lincoln Avenue
- Code information
- Lot #: 15378, Exp 3/2023; 14418 EXP 10/2021
- Postal code
- 08310
- Report date
- Sep 8, 2021
- Product type
- Drugs
- Recall number
- D-0785-2021
- Classification
- Class III
- Recalling firm
- Teligent Pharma, Inc.
- Product quantity
- 114,456 tubes
- Termination date
- Aug 15, 2024
- Reason for recall
- Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determined through routine testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Jul 29, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 31, 2021