Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-unit dose cups per case...

FDA Drug Recall #D-1053-2017 — Class II — June 26, 2017

Recall Summary

Recall Number D-1053-2017
Classification Class II — Moderate risk
Date Initiated June 26, 2017
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm VistaPharm, Inc.
Location Largo, FL
Product Type Drugs
Quantity 9945 cases

Product Description

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

Reason for Recall

Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification.

Distribution Pattern

CA, IL, LA, NH, OH, PA, SC

Lot / Code Information

Lot #: 458300, Exp 09/2018; 462600, Exp 07/2018; 471000, Exp 10/2018; 474300, Exp 11/2018

Other Recalls from VistaPharm, Inc.

Recall # Classification Product Date
D-0018-2023 Class II Pyridostigmine Bromide Oral Solution, USP 60 mg... Sep 30, 2022
D-0376-2022 Class II Clobazam Oral Suspension 2.5 mg/mL, 120 mL bott... Jan 7, 2022
D-0019-2021 Class III NYSTATIN ORAL SUSPENSION, USP 100,000 units per... Sep 25, 2020
D-1378-2020 Class III Nystatin Oral Suspension, USP 100,000 units per... Jun 23, 2020
D-1377-2020 Class III Nystatin Oral Suspension, USP 500,000 units/5mL... Jun 23, 2020

Frequently Asked Questions

Injectable drugs and eye drops must be completely free of microbial contamination because they bypass the body's natural defenses. A contaminated injectable can introduce bacteria or fungi directly into the bloodstream, potentially causing sepsis, meningitis, or localized infections — all of which can be life-threatening. Contamination of sterile products almost always results in a Class I recall. If you received an injectable drug from a recalled lot, contact your healthcare provider immediately, even if you feel well, as some infections can have delayed onset.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.