Recall Z-1953-2015— Sheffield Pharmaceuticals, LLC
Class II · Terminated
Class II FDA medical device recall by Sheffield Pharmaceuticals, LLC, initiated 2015-04-27, terminated 2016-06-10. It names one FDA 510(k) clearance: K073684. Product: Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.. Reason: Recovery of high count of gram positive rods including single colonies of B. cepacia..
- Recalling firm
- Sheffield Pharmaceuticals, LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-27
- Terminated
- 2016-06-10
- Firm location
- New London, CT, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.
Reason for recall
Recovery of high count of gram positive rods including single colonies of B. cepacia.
Data sourced from openFDA. This site is unofficial and independent of the FDA.