FDA-Drug2016-12-28Class I

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

US Compounding Inc
Hazard

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

Sold states
TX
Affected count
10,665 syringes
Manufactured in
1270 Don's Lane, N/A, Conway, AR, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0219-2017

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