Recalls / Class II
Class IID-1053-2017
Product
Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-01
- Affected lot / code info
- Lot #: 458300, Exp 09/2018; 462600, Exp 07/2018; 471000, Exp 10/2018; 474300, Exp 11/2018
Why it was recalled
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Recalling firm
- Firm
- VistaPharm, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 7265 Ulmerton Rd, N/A, Largo, Florida 33771-4809
Distribution
- Quantity
- 9945 cases
- Distribution pattern
- CA, IL, LA, NH, OH, PA, SC
Timeline
- Recall initiated
- 2017-06-26
- FDA classified
- 2017-08-01
- Posted by FDA
- 2017-08-09
- Terminated
- 2019-04-03
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1053-2017. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.