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Pharma-Natural Inc. recalls LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz (4 g) roll on bottle, Distributed by:

Recalled July 31, 2019 · FDA recall D-1499-2019 · Pharma-Natural

Hazard
CGMP Deviations: products were manufactured with lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations. · FDA Class II
Units
2000 roll on bottles
Sold at
Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.

Description

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

Product
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.
Manufacturer(s)
Pharma-Natural Inc.

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov

Pharma-Natural Inc. recalls LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz (4 g) roll on bottle, Distributed by: | RecallWatchUSA