FDA Recall Citroma

The last Recall Enforcement Report for Citroma with NDC 62011-0381 was initiated on 07-15-2022 as a Class II recall due to cgmp deviations The latest recall number for this product is D-1512-2022 and the recall is currently ongoing .

Recall Number D-1512-2022

Field Name	Field Value
Event ID	90599 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1512-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Distributed Nationwide in the USA as well as Canada and Panama. What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
Product Description	Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 FL OZ (296 mL), a) Best Choice UPC 0 70038 58790 3 Proudly Distributed By: Valu Merchandises, Co. 5000 Kansas Ave. Kansas City, KS 66106; b) Careone UPC 3 41520 00055 3 Distributed By: Foodhold U.S.A., LLC, Landover, MD 20785, Careone UPC 3 41520 00055 3 Distributed By: Adusa Distribution, LLC Salisbury, NC 28147; c) CVS Health UPC 0 50428 29733 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895, CVS Health UPC 0 50428 28515 2 Distributed by: CVS Pharmacy, Inc. One CVS Drive, Woonsocket, RI 02895; d) Equaline NDC 41163-769-38 UPC 0 41163 50068 6 Distributed by Supervalu Inc. Eden Prairie, MN 55344 USA, Equaline NDC: 41163-769-38 UPC 0 41163 50068 6 Distributed By UNFI Providence, RI 02908; Equate NDC 49035-593-38 UPC 6 81131 28716 6 Distributed By: Walmart Inc., Bentonville, AR 72716; Family Wellness NDC 56319-164-38 UPC 0 32251 57788 8; e) GoodSense NDC 50804-164-38 UPC 8 46036 00739 8 Distributed By: Geiss, Destin & Dunn, Inc. Peachtree City, GA 30269, GoodSense NDC 508-164-38 UPC 8 46036 00739 8 Distributed by: Geiss, Destin & Dunn, Inc. A Perrigo Company, Peachtree City, GA 30269; f) HEB UPC 0 41220 51087 0 Made with Pride & Care For H-E-B San Antonio, TX 78204; g) Health Mart NDC 62011-0381-1 UPC 0 52569 14216 5 Distributed by McKesson One Post Street, San Francisco, CA 94104, Health Mart NDC 62011-0381-1 NDC 0 52569 14216 5 Distributed by McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141; h) Leader Sugar-Free NDC 70000-0575-1 UPC 0 96295 14106 1 Distributed By Cardinal Health Dublin, Ohio 43017, Leader Sugar-Free NDC 70000-0576-1 UPC 0 96295 14105 4 Distributed By Cardinal Health Dublin, Ohio 43017; i) Meijer Sugar Free Low Sodium NDC 41250-769-38 UPC 7 13733 45944 0 Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544; j) Premier Value UPC 8 40986 03529 6 Distributed by: Pharmacy Value Alliance LLC 407 East Lancaster Avenue, Wayne, PA 19087; k) P NDC 56062-264-38 UPC 0 41415 50573 5 Distributed By Publix Super Markets, Inc. 3300 Publix Corporation Parkway, Lakeland, FL 33811; l) Quality Choice UPC 6 35515 90111 7 Distributed by C.D.M.A., Inc. 43157 W 9 Mile Rd Novi, MI 48375; Rexall UPC 0 72785 13416 4 Distributed By Dolgencorp, LLC 100 Mission Ridge Goodlettsville, TN 37072 USA, Rexall UPC 0 72785 13416 4 Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072; m) Rite Aid NDC 11822-4303-2 UPC 0 11822 43303 7 Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 17011; Signature Care NDC 21130-165-38 UPC 3 21130 78971 0 Distributed By Better Living Brands LLC P.O. Box 99, Pleasanton, CA 94566; n) Sunmark NDC 70677-0053-1 UPC 0 10939 91044 8 Distributed By McKesson One Post Street, San Francisco, CA 94104; o) Swan Very Low Sodium NDC 0869-0164-38 UPC 3 08690 69338 1 Distributed by: Vi-Jon, Inc. One Swan Drive Smyrna, TN 37167; p) TopCare Health NDC 36800-164-38 UPC 0 36800 45530 6 Distributed By Topco Associates LLC Elk Grove Village, IL 60007; q) Walgreens NDC 0363-8164-38 UPC 3 11917 20158 0 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 (red label), Walgreens NDC 0363-8164-38 UPC 3 11917 20158 0 Distributed By: Walgreen Co. 200 Wilmot RD., Deerfield, IL 60015
Reason For Recall	CGMP Deviations What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	10,070,526 Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	09-21-2022
Recall Initiation Date	07-15-2022 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Vi-Jon, LLC
Code Info	All lots remaining within expiry. Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	41163-769-38; 49035-593-38; 50804-164-38; 62011-0381-1; 70000-0575-1; 70000-0576-1; 41250-769-38; 56062-264-38; 11822-4303-2; 21130-165-38; 70677-0053-1; 0869-0164-38; 36800-164-38; 0363-8164-38; 56319-164-38
Status	Ongoing
	View Recall Report

What is the Enforcement Report?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.