FDA recall D-1390-2020

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.

Distribution

Nationwide within the U.S.

Key facts

Status

Terminated

Initiation date

2020-07-01

Report date

2020-07-22

Termination date

2024-04-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Anaheim, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1390-2020