Pharma-Natural product recalled over manufacturing violations

Recall date

June 21, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Pharma-Natural Inc. recalls Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle wit…

Recall number

D-1495-2019

FDA classification

Class II

Brand / firm

Pharma-Natural Inc.

Sold / distributed

Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.

Why it was recalled

CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63766-119-04.