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Sheffield Pharmaceuticals LLC

New London, CT, US

Sheffield Pharmaceuticals LLC appears in FDA device records in New London, CT. FDA records list no 510(k) clearances, no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
0
PMA records
0
Recall records
1
Registered establishments
1

510(k) clearance history

No 510(k) clearance records for this company in the ingested FDA data.

No 510(k) clearance records in the ingested FDA data.

Registered establishments

FDA registered establishments for Sheffield Pharmaceuticals LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
12105131210513Sheffield Pharmaceuticals LLC170 Broad St, NEW LONDON, CT 06320 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-1953-2015Dr. 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.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain