Drug 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
D-0219-2017
Product summary
- Event
- Event 74792
- Status
- Terminated
- Classification
- Class I
- Quantity
- 10,665 syringes
- Official record key
drug-enforcement:D-0219-2017
Official wording
Reason: Microbial Contamination of Non-Sterile Products; microbial contamination with B. cepacia
Code information: All Lots
Distribution pattern: TX
Derived failure modes
-
Microbial contamination
Microbial Contamination