Recalls / Class II
Class IID-0146-2017
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.
- Affected lot / code info
- Lot No. 378300, Exp 11/16
Why it was recalled
Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.
Recalling firm
- Firm
- VistaPharm, Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, N/A, Largo, Florida 33771-4809
Distribution
- Quantity
- 1497 cases
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2016-11-09
- FDA classified
- 2016-11-22
- Posted by FDA
- 2016-11-30
- Terminated
- 2021-09-24
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0146-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.