Class II
Terminated
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.
This recall has been terminated (originally issued November 30, 2016).
- Company
- Vistapharm, Inc.
- Recall Initiated
- November 9, 2016
- Posted
- November 30, 2016
- Recall Number
- D-0146-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1497 cases
- Firm Location
- Largo, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Distribution
Nationwide
Lot / Code Info
Lot No. 378300, Exp 11/16
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