Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), a) C...
FDA Drug Recall #D-1511-2022 — Class II — July 15, 2022
Recall Summary
| Recall Number | D-1511-2022 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 15, 2022 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Vi-Jon, LLC |
| Location | Smyrna, TN |
| Product Type | Drugs |
| Quantity | 22,965,330 bottles |
Product Description
Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 FL OZ (296 mL), a) CVS Health UPC 0 50428 33517 8 or UPC 0 50428 30594 2 Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895; b) Best Choice UPC 0 70038 20049 9 Proudly Distributed By: Valu Merchandisers, Co. 5000 Kansas Ave Kansas City, KS 66106; c) Care One UPC 3 41520 31322 6 Distributed By: Foodhold U.S.A., LLC, Landover, MD 20785 or Distributed By: Adusa Distribution, LLC Salisbury, NC 28147; d) Cariba UPC 6 46702 05701 2 Distributed by: Cariba International P.O. Box 1208 Safety Harbor, Florida 34595; e) Cruz Blanca UPC 3 0869-7403-08 2 or 3 08697 40308 2 Fabricado por Vi-Jon Inc. Smyrna, TN 37167 U.S.A. Dist.; f) Discount Drug Mart UPC 0 93351 02820 5 Distributed By: Discount Drug Mart 211 Commerce Drive, Medina, Ohio 44256; g) Equaline NDC 41163-709-38 UPC 0 41163 50067 9 Distributed by SUPERVALU INC. Eden Prairie, MN 55344 USA or Distributed By UNFI Providence, RI 02908 USA; h) Equate NDC 49035-506-38 UPC 6 81131 28714 2 Distributed By: Walmart Inc., Bentonville, AR 72716; i) Exchange Select 6 14299 40420 5 Manufactured For Your Military Exchanges By: Vi-Jon Inc. 8515 Page Avenue, St. Louis, MO 63114; j) Family Wellness UPC 0 32251 58082 6 Distributed By: Midwood Brands, LLC 500 Volvo Parkway Chesapeake, VA 23330; k) Good Sense NDC 50804-166-38 UPC 8 46036 00737 4 Distributed By: Geiss, Destin & Dunn, Inc. Peachtree City, GA 30269 or Distributed by: Perrigo Direct, Inc. Peachtree City, GA 30269; l) Harris Teeter UPC 0 72036 72612 4 Proudly Distributed By: Harris Teeter, LLC Matthews, NC 28105; m) HEB UPC 0 41220 51086 3 Made With Pride & Care For H-E-B San Antonio, TX 78204; n) Health Mart NDC 62011-0380-1 UPC 0 52569 14215 8 Distributed by McKesson One Post Street, San Francisco, CA 94104; o) Kroger NDC 30142-899-38 UPC 0 41260 00182 6 Distributed By The Kroger CO Cincinnati, Ohio 45202; p) Leader Sugar-Free NDC 70000-0424-1 UPC 0 96295 13554 1 Distributed By Cardinal Health Dublin, OH 43017; q) Major NDC 0904-6787-44 UPC 3 09046 78744 0 Distributed By: Major Pharmaceuticals 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152; r) Meijer NDC 41250-708-38 UPC 7 13733 45945 7 Dist. By Meijer Distribution, Inc. Grand Rapids, MI 49544; s) Premier Value UPC 8 40986 03530 2 Distributed by: Pharmacy Value Alliance LLC. 407 East Lancaster Avenue, Wayne, PA 19087; t) Publix NDC 56062-266-38 UPC 0 41415 50673 2 Distributed By Publix Super Markets, Inc. 3300 Publix Corporate Parkway, Lakeland, FL 33811; u) Quality Choice UPC 6 35515 90125 4 Distributed by C.D.M.A., Inc. 43157 W 9 Mile Rd Novi, MI 48375; v) Rexall UPC 0 72785 13418 8 Distributed By Dolgencorp. LLC 100 Mission Ridge Goodlettsville, TN 37072 or Distributed By Old East Main Co. 100 Mission Ridge Goodlettsville, TN 37072; w) Rite Aid NDC 11822-4330-2 UPC 0 11822 43300 6 Distributed By: Rite Aid 30 Hunter Lane Camp Hill, PA 1701; x) Signature Care NDC 21130-709-38 UPC 3 21130 77915 5 Distributed By: Better Living Brands LLC P.O. Box 99, Pleasanton, CA 94566-0009; y) Sound Body UPC 0 72785 11479 1 Manufactured for Big Lots by: Vi-Jon, Inc. 8515 Page Avenue; St. Louis, MO 63114; z) Sunmark NDC 70677-0051-1 UPC 0 10939 90844 5 Distributed By McKesson One Post Street, San Francisco, CA 94104 or Distributed by McKesson Corp., via Strategic Sourcing Services LLC, Memphis, TN 38141; aa) Swan NDC 0869-0166-38 UPC 0 72785 13405 8 Distributed by: Vi-Jon, Inc. One Swan Drive Smyrna, TN 37167; bb) Topcare health UPC 0 36800 45529 0 Distributed By Topco Associates, LLC. Elk Grove Village, IL 60007; cc) Up & Up NDC 11673-708-38 or NDC 11673-666-38 UPC 0 72785 12883 5 Dist. by Target Corp., Mpls., MN 55403; dd) Walgreens NDC 0363-8166-38 UPC 3 11917 20160 3 Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015
Reason for Recall
CGMP Deviations
Distribution Pattern
Distributed Nationwide in the USA as well as Canada and Panama.
Lot / Code Information
All lots remaining within expiry.
Other Recalls from Vi-Jon, LLC
| Recall # | Classification | Product | Date |
|---|---|---|---|
| D-1173-2023 | Class III | Kroger Mint Burst ANTISEPTIC MOUTH RINSE ANTIGI... | Sep 5, 2023 |
| D-1509-2022 | Class I | Walgreens, Dye-Free, Magnesium Citrate, SALINE ... | Jul 15, 2022 |
| D-1503-2022 | Class I | Kroger, Magnesium Citrate SALINE LAXATIVE, Oral... | Jul 15, 2022 |
| D-1501-2022 | Class I | equate Magnesium Citrate, SALINE LAXATIVE, (1.7... | Jul 15, 2022 |
| D-1505-2022 | Class I | P, magnesium citrate SALINE LAXATIVE, Oral Solu... | Jul 15, 2022 |
Frequently Asked Questions
cGMP stands for Current Good Manufacturing Practice — the FDA's regulations governing drug manufacturing quality. A cGMP recall means the company failed to follow required manufacturing standards. This could involve inadequate testing, poor environmental controls, documentation failures, or process deviations. cGMP recalls do not always mean the product is directly harmful — in many cases, quality records are insufficient to confirm the product meets specifications. However, the FDA requires a recall because without proper documentation, product quality cannot be assured. These are often Class II or Class III recalls.
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.