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
- Affected units
- 74
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.
Part of a larger recall action
This product is one of 56 recalled by Edge Pharma, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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