Why it was recalled
cGMP Deviations
Product description
Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA
Lot numbers, UPCs & expiration codes
Lot #: a) 16291, Exp. Date 01/2024;16469, Exp. Date 02/2024; b)16255, Exp. Date 11/2022; 16256, 16412 Exp. Date 02/2024; 16257, 16258, Exp. Date12/2022; 16505, 6506, Exp. Date 03/2024; 16627,16786, 16787,16820, Exp. Date 04/2024.
Where it was sold
Nationwide within the United States
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-0794-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Apr 15, 2022
- FDA report date
- May 4, 2022
- Quantity
- 353964 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Teva Pharmaceuticals USA Inc
Original FDA data
Every field from FDA enforcement report D-0794-2022, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 89944
- Address
- 400 Interpace Pkwy Bldg A
- Code information
- Lot #: a) 16291, Exp. Date 01/2024;16469, Exp. Date 02/2024; b)16255, Exp. Date 11/2022; 16256, 16412 Exp. Date 02/2024; 16257, 16258, Exp. Date12/2022; 16505, 6506, Exp. Date 03/2024; 16627,16786, 16787,16820, Exp. Date 04/2024.
- Postal code
- 07054-1120
- Report date
- May 4, 2022
- Product type
- Drugs
- Recall number
- D-0794-2022
- Classification
- Class II
- Recalling firm
- Teva Pharmaceuticals USA Inc
- Product quantity
- 353964 units
- Termination date
- May 25, 2023
- Reason for recall
- cGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Apr 15, 2022
- Center classification date
- Apr 27, 2022