FDA Medical Device Recalls (openFDA)
Sheffield Pharmaceuticals, LLC: Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
- Recall number
- Z-1953-2015
- Recalling firm
- Sheffield Pharmaceuticals, LLC
- Product
- Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
- Status
- Terminated
- Initiated
- 2015-04-27
- Posted
- 2015-07-02
- Terminated
- 2016-06-10
- 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.
- Lot, serial or model codes
- Lot Numbers: 40131 EXP 01/18 ; 40132 EXP 01/18; 40141 EXP 01 /18
- 510(k) numbers
- ["K073684"]
- PMA numbers
- not on file
- Product code
- MMS
- Firm FEI
- 1210513
- Firm city
- New London
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28