FDAClass IDecember 28, 2016

Docusate Oral 10 mg/mL Oral Syringe recall: Sterility Concern

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

Why was Docusate Oral 10 mg/mL Oral Syringe recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

All Lots

Product
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
Recalling firm
US Compounding Inc
Quantity
10,665 syringes
Distribution
TX
Recall date
December 28, 2016
Classification
Class I
Status
Terminated
Agency
FDA (drug)
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