Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
FDA device recall Z-1953-2015 · posted 2015-07-02 · Terminated
Recall details
- Recalling firm
- Sheffield Pharmaceuticals, LLC
- Reason for recall
- Recovery of high count of gram positive rods including single colonies of B. cepacia.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MMS
- Quantity affected
- 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.
- Date initiated
- 2015-04-27
- Date posted
- 2015-07-02
- Date terminated
- 2016-06-10
- Location
- New London, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL (K073684) | Sheffield Industries, Div. of Faria , Ltd. | 2008-05-22 |