PlainRecalls
FDA Drug Moderate Class II Terminated

LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz (4 g) roll on bottle, Distributed by: Diabetic Supply of Suncoast, Inc., dba Advocate Diabetes, PO Box 2102, Vega Alta, PR 00692, NDC 63788-114-04.

Reported: July 31, 2019 Initiated: June 21, 2019 #D-1499-2019

Product Description

LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz (4 g) roll on bottle, Distributed by: Diabetic Supply of Suncoast, Inc., dba Advocate Diabetes, PO Box 2102, Vega Alta, PR 00692, NDC 63788-114-04.

Reason for Recall

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

Details

Recalling Firm
Pharma-Natural Inc.
Units Affected
2000 roll on bottles
Distribution
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Location
Miami Lakes, FL

Frequently Asked Questions

What product was recalled?
LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz (4 g) roll on bottle, Distributed by: Diabetic Supply of Suncoast, Inc., dba Advocate Diabetes, PO Box 2102, Vega Alta, PR 00692, NDC 63788-114-04.. Recalled by Pharma-Natural Inc.. Units affected: 2000 roll on bottles.
Why was this product recalled?
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.
Which agency issued this recall?
This recall was issued by the FDA Drug on July 31, 2019. Severity: Moderate. Recall number: D-1499-2019.