FDAFDA · Food and drugs·Recall number D-1390-2020
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, Inc., The Physicians Solutions.
Published July 22, 2020 · Recall initiated: July 1, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Preferred Pharmaceuticals, Inc.
- Distributor
- Nationwide within the U.S.
- Lot
- Lot Numbers: H0218Z, H1518J, I2018L, J2918C, L1018Q, A0419M, G0519G; Exp: 5/31/2021.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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