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D-0219-2017 Class I Terminated

Recalled by US Compounding Inc — Conway, AR

FDA drug recall D-0219-2017 was initiated by US Compounding Inc on Jul 25, 2016 and is designated Class I. Reason for recall: Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia The recall status is terminated (terminated Apr 6, 2017). Affected quantity: 10,665 syringes.

Recall Details

Product Type: Drugs
Report Date: Dec 28, 2016
Initiation Date: Jul 25, 2016
Termination Date: Apr 6, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 10,665 syringes

Product Description

Docusate Oral 10 mg/mL Oral Syringe, packaged in a) 1 mL (62295-0601-01), b) 2 mL ( 62295-0601-02), and c) 5 mL syringes (62295-0601-05), US Compounding, Conway, AR

Reason for Recall

Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia

Distribution Pattern

Code Information

All Lots

Source

Dataset: openFDA drug recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for D-0219-2017
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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