Recall Z-1953-2015 ยท MMS Lubricant, Vaginal, Patient
Sheffield Pharmaceuticals, LLC
Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
| Date | Jul 2, 2015 (initiated Apr 27, 2015) |
| Status | Terminated |
| Reason | Recovery of high count of gram positive rods including single colonies of B. cepacia. |
| Root cause | Process control |
| 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 James.Turner@sheffield-pharmaceuticals.com. |
| Quantity | 37,636 pieces |
| Distribution | Worldwide Distribution -- CA, NJ, FL, PR, NJ, MI, NY, NC, FL, IL, GA, MN, KS, and NC; and, the countries of Jamaica and Georgia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K073684 | SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL Sheffield Industries, Div. of Faria , Ltd., May 22, 2008 |