FDA-Drug2019-07-31Class II

Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (113 g) jar, Distributed by Diabetic Supply of Suncoast, Inc., P.O. Box 2102, Vega Alta, PR 00692, NDC 63788-115-04.

Pharma-Natural Inc.
Hazard

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

Sold states
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Affected count
1070 jars
Manufactured in
14500 Nw 60th Ave Bldg 7f, N/A, Miami Lakes, FL, United States
Products
Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (113 g) jar, Distributed by Diabetic Supply of Suncoast, Inc., P.O. Box 2102, Vega Alta, PR 00692, NDC 63788-115-04.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1501-2019

Don't want to check this manually?

We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.

Get the Sunday Brief