Why it was recalled
CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
Product description
Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64
Lot numbers, UPCs & expiration codes
Lots: 15597, Exp.: 05/31/2023; 16305, Exp.: 12/23/2023; 16334, Exp.: 01/31/2024; 16340, Exp.: 01/31/2024; 16346 Exp.: 01/31/2024; 16356, Exp.: 01/31/2024; 16357, Exp.: 01/31/2024
Where it was sold
Nationwide in the United States including Guam and the Northern Mariana Islands.
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-0848-2022
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 21, 2022
- FDA report date
- May 11, 2022
- Quantity
- 81,757 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- McKesson Corporation dba McKesson Drug Company
Original FDA data
Every field from FDA enforcement report D-0848-2022, exactly as published.
Show all FDA fields
- City
- Memphis
- State
- TN
- Status
- Ongoing
- Country
- United States
- Event ID
- 89986
- Address
- 4853 Crumpler Rd
- Code information
- Lots: 15597, Exp.: 05/31/2023; 16305, Exp.: 12/23/2023; 16334, Exp.: 01/31/2024; 16340, Exp.: 01/31/2024; 16346 Exp.: 01/31/2024; 16356, Exp.: 01/31/2024; 16357, Exp.: 01/31/2024
- Postal code
- 38141-8301
- Report date
- May 11, 2022
- Product type
- Drugs
- Recall number
- D-0848-2022
- Classification
- Class II
- Recalling firm
- McKesson Corporation dba McKesson Drug Company
- Product quantity
- 81,757 bottles
- Reason for recall
- CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc.is discontinuing its stability study program.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL bottle, Rx only, Manufactured by: Teligent Pharma, Inc. Buena, NJ 08310 Distributed by: McKesson Corporation dba Sky Packaging 4071 Southridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-977-64
- Distribution pattern
- Nationwide in the United States including Guam and the Northern Mariana Islands.
- Recall initiation date
- Apr 21, 2022
- Initial firm notification
- Letter
- Center classification date
- May 5, 2022