Why it was recalled
CGMP Deviations
Product description
BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1235-01
Lot numbers, UPCs & expiration codes
06-2021-10@11 12-07-2021, 06-2021-10@9 12-07-2021, 06-2021-17@6 12-14-2021, 06-2021-17@7 12-14-2021, 06-2021-24@5 12-21-2021, 06-2021-24@8 12-21-2021, 07-2021-01@6 12-28-2021, 07-2021-01@7 12-28-2021, 07-2021-09@5 01-01-2022, 07-2021-09@6 01-05-2022, 07-2021-15@5 01-01-2022, 07-2021-15@6 01-01-2022, 07-2021-22@16 01-19-2022, 07-2021-22@8 01-01-2022, 07-2021-29@12 01-25-2022, 07-2021-29@24 01-25-2022, 08-2021-05@7 02-01-2022, 08-2021-05@8 02-01-2022, 08-2021-19@7 02-15-2022, 08-2021-19@8 02-15-2022, 08-2021-26@5 02-22-2022, 09-2021-01@10 02-28-2022, 09-2021-03@7 03-02-2022, 09-2021-09@7 03-08-2022, 09-2021-16@7 03-15-2022, 09-2021-17@7 03-16-2022, 09-2021-22@8 03-21-2021, 09-2021-23@2 03-22-2022, 09-2021-23@3 03-22-2022, 09-2021-30@10 03-29-2022, 09-2021-30@8 03-29-2022, 10-2021-07@10 04-05-2022, 10-2021-07@7 04-05-2022, 10-2021-08@1 04-06-2022, 10-2021-14@4 04-12-2022, 10-2021-14@5 04-12-2022, 10-2021-21@7 04-19-2022 & 10-2021-28@3 04-26-2022
Where it was sold
nationwide
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-0428-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Dec 6, 2021
- FDA report date
- Feb 2, 2022
- Quantity
- 1173 jars
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Edge Pharma, LLC
Original FDA data
Every field from FDA enforcement report D-0428-2022, exactly as published.
Show all FDA fields
- City
- Colchester
- State
- VT
- Status
- Terminated
- Country
- United States
- Event ID
- 89172
- Address
- 856 Hercules Dr
- Code information
- 06-2021-10@11 12-07-2021, 06-2021-10@9 12-07-2021, 06-2021-17@6 12-14-2021, 06-2021-17@7 12-14-2021, 06-2021-24@5 12-21-2021, 06-2021-24@8 12-21-2021, 07-2021-01@6 12-28-2021, 07-2021-01@7 12-28-2021, 07-2021-09@5 01-01-2022, 07-2021-09@6 01-05-2022, 07-2021-15@5 01-01-2022, 07-2021-15@6 01-01-2022, 07-2021-22@16 01-19-2022, 07-2021-22@8 01-01-2022, 07-2021-29@12 01-25-2022, 07-2021-29@24 01-25-2022, 08-2021-05@7 02-01-2022, 08-2021-05@8 02-01-2022, 08-2021-19@7 02-15-2022, 08-2021-19@8 02-15-2022, 08-2021-26@5 02-22-2022, 09-2021-01@10 02-28-2022, 09-2021-03@7 03-02-2022, 09-2021-09@7 03-08-2022, 09-2021-16@7 03-15-2022, 09-2021-17@7 03-16-2022, 09-2021-22@8 03-21-2021, 09-2021-23@2 03-22-2022, 09-2021-23@3 03-22-2022, 09-2021-30@10 03-29-2022, 09-2021-30@8 03-29-2022, 10-2021-07@10 04-05-2022, 10-2021-07@7 04-05-2022, 10-2021-08@1 04-06-2022, 10-2021-14@4 04-12-2022, 10-2021-14@5 04-12-2022, 10-2021-21@7 04-19-2022 & 10-2021-28@3 04-26-2022
- Postal code
- 05446-8014
- Report date
- Feb 2, 2022
- Product type
- Drugs
- Recall number
- D-0428-2022
- Classification
- Class II
- Recalling firm
- Edge Pharma, LLC
- Product quantity
- 1173 jars
- Termination date
- Jun 7, 2023
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1235-01
- Distribution pattern
- nationwide
- Recall initiation date
- Dec 6, 2021
- Initial firm notification
- Press Release
- Center classification date
- Jan 24, 2022