Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
FDA Recall Z-1953-2015 · Posted 2015-07-02
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Recalling FirmSheffield Pharmaceuticals, LLC
Recall StatusTerminated
Product CodeMMS
Date Initiated2015-04-27
Date Terminated2016-06-10
Product Quantity37,636 pieces
Reason for Recall
Recovery of high count of gram positive rods including single colonies of B. cepacia.
Firm Action
A letter was sent to inform customers of the voluntary recall of Sheffield Pharmaceuticals Lubri-Gel Personal Lubricant Jelly. The letter described the issue and asked customers to quarantine all related inventory immediately and provide their inventory counts on the specific lots. Questions or concerns related to the recall or letter can be directed to James Turner at [email protected].
Root Cause
Process control
Distribution Pattern
Worldwide Distribution -- CA, NJ, FL, PR, NJ, MI, NY, NC, FL, IL, GA, MN, KS, and NC; and, the countries of Jamaica and Georgia.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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