Drug product
Lactulose Solution, USP 10 g/15 mL, 50 unit dose cups of 15 mL per case, Rx only, Manufactured by VistaPharm, Largo, FL 33771, NDC No. 66689-039-50.
D-0463-2017
Product summary
- Firm
- VistaPharm, Inc.
- Event
- Event 75650
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7,404 unit dose cups
- Official record key
drug-enforcement:D-0463-2017
Official wording
Reason: CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated with Burkholderia cepacia.
Code information: a). Lot No. 728300 (Exp. 11/17), 423200 (Exp. 10/17), 418400 (Exp. 09/17), 411100 (Exp. 07/17), 406500 (Exp. 06/17)
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Microbial contamination
contaminated with Burkholderia cepacia