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, Pr

FDA recall notice · announced July 22, 2020 · Preferred Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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, Inc., The Physicians Solutions.

Reason for recall

CGMP Deviations: Contract Manufacturing Organization (CMO) misplaced/lost batch records and test results for the recalled batch.

Notes

Distribution: Nationwide within the U.S.
Lot/code information: Lot Numbers: H0218Z, H1518J, I2018L, J2918C, L1018Q, A0419M, G0519G; Exp: 5/31/2021.
Quantity: N/A
Status: Terminated
Products in this recall event:
- 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 Pha (D-1390-2020)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.