Home / Recalls / Edge Pharma, LLC / D-0428-2022

D-0428-2022 Class II Terminated

Recalled by Edge Pharma, LLC — Colchester, VT

Recall Details

Product Type
Drugs
Report Date
February 2, 2022
Initiation Date
December 6, 2021
Termination Date
June 7, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1173 jars

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

Distribution Pattern

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

Other recalls by Edge Pharma, LLC

  • D-0434-2022 Class II — Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL per v (December 6, 2021)
  • D-0420-2022 Class II — Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL per d (December 6, 2021)
  • D-0415-2022 Class II — Phenylephrine HCl 0.5 mg/5mL, (0.1 mg/mL), 5 mL per syringe, Single Use Syringe (December 6, 2021)
  • D-0436-2022 Class II — LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Cont (December 6, 2021)
  • D-0444-2022 Class II — Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Multip (December 6, 2021)
  • D-0412-2022 Class II — MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/0.1 (December 6, 2021)
  • D-0403-2022 Class II — Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg/mL (December 6, 2021)
  • D-0419-2022 Class II — Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Preserva (December 6, 2021)
  • D-0405-2022 Class II — Methacholine Challenge 5-Syringe Test Kit, Sterile Inhalation Solution, Preserva (December 6, 2021)
  • D-0418-2022 Class II — PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL), S (December 6, 2021)