Preferred Pharmaceuticals Recalls Lidothol Patches Due to Missing Batch Records
Preferred Pharmaceuticals is recalling Lidothol Patches because the contract manufacturer misplaced or lost batch records and test results.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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: The recall is classified as FDA Class II and involves CGMP deviations (missing records) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Preferred Pharmaceuticals, Inc. is recalling Lidothol Patches, Lidocaine 4.5% & Menthol 5%. The product is a topical anesthetic and analgesic available in boxes of 15 patches. The recall is due to Current Good Manufacturing Practice (CGMP) deviations where the contract manufacturing organization misplaced or lost batch records and test results for the affected batches.
The affected lot numbers are H0218Z, H1518J, I2018L, J2918C, L1018Q, A0419M, and G0519G, with an expiration date of 5/31/2021. The product was distributed nationwide within the U.S. The source text does not report any illnesses or injuries associated with this recall.
Consumers should check their Lidothol Patches for the listed lot numbers. If the product matches the recalled lots, consumers should stop using it and contact their healthcare provider or the recalling firm for instructions on disposal or return.
The recalled product
- Product
- Lidothol Patch, Lidocaine 4.5% & Menthol 5%, In each patch: lidocaine 4.5% topical anesthetic, menthol 5% topical analgesic, Pkg Size 15 patches per box, Insurance NDC: 53225-1025-01, Mfg: Terrain Pharmaceuticals; Reno, NV, Prod # (NDC): 68788-7405-01, Preferred Pharmaceuticals…
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Category
- Drug — Topical Anesthetic
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 (8)
- Lot Numbers: H0218Z
- H1518J
- I2018L
- J2918C
- L1018Q
- A0419M
- G0519G
- Exp: 5/31/2021.
Distribution
Distributed nationwide across the United States.
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