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

FDA recall notice · announced December 28, 2016 · Us Compounding

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The 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

Reason for recall

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

Notes

Distribution: TX
Lot/code information: All Lots
Quantity: 10,665 syringes
Status: Terminated
Products in this recall event:
- 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 (D-0219-2017)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.