D-1390-2020 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- July 22, 2020
- Initiation Date
- July 1, 2020
- Termination Date
- April 17, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
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.
Distribution Pattern
Nationwide within the U.S.
Code Information
Lot Numbers: H0218Z, H1518J, I2018L, J2918C, L1018Q, A0419M, G0519G; Exp: 5/31/2021.