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Sheffield Pharmaceuticals LLC: FDA-registered device maker in New London, CT, United States, 2 510(k) clearances

Name: Sheffield Pharmaceuticals LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Sheffield Pharmaceuticals LLC is registered with the FDA (registration 1210513) in New London, CT, United States. It lists 7 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 6, 2006. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1210513
Address: 170 Broad St, New London, CT, United States, 06320
Owner or operator: Sheffield Pharmaceuticals LLC (1210513)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Repackager or relabeler, Specification developer
First device listed: December 17, 2008
Registered through: 2026
Brand names listed: ACRYLINE Denture reliner, Care One Lubricating Jelly, Cleanadent, Combe Denture Adhesive Cream, Dawn Mist Denture Adhesive, Dollar General Ear Wax Remover Kit, Dr. Berland's Adhesadent Moisturizing Denture Adhesive, Dr. Sheffield Staydent Adhesive and more

Devices it lists

Device	Product code	Class	Role	Source
Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt	KOO	1	Manufacturer	accessdata.fda.gov
Cleanser, Denture, Over The Counter	EFT	1	Contract manufacturer	accessdata.fda.gov
Finger Cot	LZB	1	Specification developer	accessdata.fda.gov
Lubricant, Personal	NUC	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Nasal Spray, Ent Delivery	KCO	1	Contract manufacturer, Manufacturer	accessdata.fda.gov
Reliner, Denture, Over The Counter	EBP	2	Complaint file establishment, Specification developer	accessdata.fda.gov
Syringe, Irrigating (Non Dental)	KYZ	1	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
February 6, 2006	K052162	SHEFFIELD BRAND WARMING LUBRIGEL PERSONAL LUBRICANT	NUC	Substantially Equivalent	Sheffield Laboratories, Div. of Faria Limited, LLC	accessdata.fda.gov
August 2, 2000	K001077	LUBRIGEL PERSONAL LUBRICANT	NUC	Substantially Equivalent	Sheffield Laboratories, Div. of Faria Limited, LLC	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
April 27, 2015	71129	Class II	Terminated	Dr. Sheffield's LUBRI GEL 3 oz (85 g) Non sterile over-the-counter personal lubricant.	Recovery of high count of gram positive rods including single colonies of B. cepacia.	accessdata.fda.gov

Compare with other makers

Updated July 2, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.