BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, Multiple Dose Contai...
FDA Recall #D-0428-2022 — Class II — December 6, 2021
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
Reason for Recall
CGMP Deviations
Recalling Firm
Edge Pharma, LLC — Colchester, VT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1173 jars
Distribution
nationwide
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
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated