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
Reported: December 28, 2016 Initiated: July 25, 2016 #D-0219-2017
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
Details
- Recalling Firm
- US Compounding Inc
- Units Affected
- 10,665 syringes
- Distribution
- TX
- Location
- Conway, AR
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by US Compounding Inc. Units affected: 10,665 syringes.
Why was this product recalled? ▼
Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 28, 2016. Severity: Critical. Recall number: D-0219-2017.
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