Drug product
Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.
D-0146-2017
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 75752
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1497 cases
- Official record key
drug-enforcement:D-0146-2017
Official wording
Reason: Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Code information: Lot No. 378300, Exp 11/16
Distribution pattern: Nationwide
Derived failure modes
-
Microbial contamination
Microbial Contamination