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D-0277-2016 Class II Terminated

Recalled by US Compounding Inc — Conway, AR

FDA drug recall D-0277-2016 was initiated by US Compounding Inc on Sep 12, 2015 and is designated Class II. Reason for recall: Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance. The recall status is terminated (terminated Mar 30, 2017). Affected quantity: 3,860 dropper bottles.

Recall Details

Product Type: Drugs
Report Date: Nov 25, 2015
Initiation Date: Sep 12, 2015
Termination Date: Mar 30, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 3,860 dropper bottles

Product Description

Phenylephrine PF Sterile Solution (2.5%), 3 mL Single Use Ophthalmic Dropper For Topical Ophthalmic Use, Rx only, Compounded by US Compounding Pharmacy, Conway, Arkansas, 72032, NDC 62295-3272-03

Reason for Recall

Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

Distribution Pattern

Nationwide

Code Information

Lot Code: 20150206@3 BUD: 11/29/2015, 20150306@51 BUD: 11/30/2015, 20151106@28 BUD: 12/8/2015, 20151404@4 BUD: 10/11/2015, 20151606@3 BUD: 12/13/2015

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0277-2016
openFDA file date: Nov 3, 2026
Loaded by RegDataLab: Nov 4, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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