FDA Recall D-0228-2024

Pharma Nobis LLC · Texarkana, TX

Class II Ongoing 875 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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: Lot A80623; Exp. 11/30/2025

Quantity: 49,716 Bottles

Reason for recall

MICROBIAL CONTAMINATION OF NON-STERILE PRODUCTS - Presence of Acetobacter nitrogenifigens bacteria.

Recall record

Recall number: D-0228-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide.
Recall initiated: 2023-12-21
Classified by FDA Center: 2024-01-12
FDA published: 2024-01-24
Recalling firm: Pharma Nobis LLC
Firm location: Texarkana, TX

Drug identification

Brand name(s): MAGNESIUM CITRATE
Generic name(s): MAGNESIUM CITRATE
Manufacturer(s): WALGREEN COMPANY
NDC(s): 0363-0427
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

‹ All recalls