Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free Low Sodium, Grape flavor 10 fl. oz, Distr
Summary
The FDA issued a Class II for Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free L by Pharma Nobis LLC. Reason: MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria..
Details
Source
Drug Recall
External ID
D-0228-2024
Action Date
2024-01-24
Status
Ongoing
Category
drug
Product Description
Walgreens Dye-Free Magnesium Citrate Saline Laxative/Oral Solution, Sugar Free Low Sodium, Grape flavor 10 fl. oz, Distributed by: Walgreen Co, 200 Wilmot Rd, Deerfield, IL 60015, NDC 0363-0427-98.
Lot/Code Info: Lot A80623; Exp. 11/30/2025
Quantity Affected: 49,716 Bottles
Reason for Recall
MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.
Distribution
Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-12-21
Company
Texarkana, TX
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 44 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Pharma Nobis LLC has 8 FDA actions in our database, including 8 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Pharma Nobis LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Pharma Nobis LLC have FDA actions?
Pharma Nobis LLC has 8 FDA actions in our database, including 8 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0228-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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