Why it was recalled
Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
Product description
Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50
Lot numbers, UPCs & expiration codes
Lot #: 468300, Exp 09/2018; 474400, Exp 11/2018
Where it was sold
CA, IL, LA, NH, OH, PA, SC
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1052-2017
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jun 26, 2017
- FDA report date
- Aug 9, 2017
- Quantity
- 6150 cases
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- VistaPharm, Inc.
Original FDA data
Every field from FDA enforcement report D-1052-2017, exactly as published.
Show all FDA fields
- City
- Largo
- State
- FL
- Status
- Terminated
- Country
- United States
- Event ID
- 77638
- Address
- 7265 Ulmerton Rd
- Code information
- Lot #: 468300, Exp 09/2018; 474400, Exp 11/2018
- Postal code
- 33771-4809
- Report date
- Aug 9, 2017
- Product type
- Drugs
- Recall number
- D-1052-2017
- Classification
- Class II
- Recalling firm
- VistaPharm, Inc.
- Product quantity
- 6150 cases
- Termination date
- Apr 3, 2019
- Reason for recall
- Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-unit dose cups per case, Manufactured by VistaPharm, Inc., Largo, FL 33771, NDC 66689-038-50
- Distribution pattern
- CA, IL, LA, NH, OH, PA, SC
- Recall initiation date
- Jun 26, 2017
- Initial firm notification
- Letter
- Center classification date
- Aug 1, 2017