The Recall Desk
ModerateFDA (Drugs)·D-0436-2022·Announced 2022-02-02

LT Topical Cream Recalled for Manufacturing Practice Deviations

Edge Pharma, LLC is recalling 74 jars of LT Topical Cream (Lidocaine/Tetracaine) nationwide due to deviations from Current Good Manufacturing Practice (CGMP). The firm initiated the voluntary recall on December 6, 2021.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving manufacturing practice deviations with no reported illnesses or injuries documented in the source text. Manufacturing compliance issues without confirmed harm or high-risk contamination fall within the Moderate category under the severity rubric.

Plain-English summary

Edge Pharma, LLC is recalling LT Topical Cream, a Lidocaine/Tetracaine topical cream (23%/7%, 60 grams per jar), NDC 05446-1647-01, distributed nationwide. A total of 74 jars are affected by this recall.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations identified during manufacturing. This is a voluntary, firm-initiated recall announced on December 6, 2021.

Affected lot codes are: 08-2021-23@9 (dated 02-19-2022), 09-2021-07@13 (dated 03-06-2022), and 10-2021-22@5 (dated 04-20-2022).

Consumers or healthcare providers who have this product should not use it and should contact Edge Pharma, LLC for instructions on proper return or disposal. The recall was terminated on June 7, 2023.

The recalled product

Product
LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC, 856 Hercules, VT, Colchester, VT 05446, NDC 05446-1647-01
Manufacturer
Edge Pharma, LLC
Category
Drug — Topical Preparation
Hazard
  • cGMP-deviation
  • manufacturing-defect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • 08-2021-23@9 02-19-2022
  • 09-2021-07@13 03-06-2022 & 10-2021-22@5 04-20-2022.

Distribution

Distributed nationwide across the United States.

Related recalls

Same category