Class III · Low risk
Magnesium Chloride
Subpotent drug
Antacid Liquid Regular Strength Antacid & Anti-Gas
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Microbial Contamination of Non-Sterile Products: Lots failed microbiological testing at the 12-month time point.
Cause type: Microbial contamination
Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.
What was recalled
Antacid Liquid Regular Strength Antacid & Anti-Gas (Aluminum hydroxide 200 mg, Magnesium hydroxide 200 mg, Simethicone 20 mg (in each 5 mL, 1 teaspoon), Mint flavor, 12 fl oz (355 mL) bottle, Distributed By: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-0073-02, UPC 3 11917 15114 4.
Affected NDC
0363-0073-02
Compare with the code on your package — it is the most precise check available.
Drug: Magnesium
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Soothe Bismuth subsalicylate NDC 00363-0073 |
525 mg/30mL | Liquid Oral |
Walgreens | OTC |
- Recalling firm
- Tarmac Products, Inc.
- NDC code
- 0363-0073-02
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0419-2015 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Magnesium recalls
See all
Class I · High risk
Magnesium Sulfate in Water for Injection
Product mix up: a foil pouch labeled "Magnesium Sulfate in Water for Injection, 4 g/100 mL" actually contained an IV bag of Tranexamic Acid instead.
Class II · Moderate risk
INON ACE Antacid tablets
Failed Disintegration Specifications: above the time expected.
Class II · Moderate risk
Magnesium Chloride for Injection
Lack of Assurance of Sterility
Class II · Moderate risk
Glutathione Magnesium for Injection
Lack of Assurance of Sterility
Other recalls by Tarmac Products, Inc.
All 2015 recalls
Class II · Moderate risk
Well at Walgreens Regular Strength Antacid Liquid
Products failed the Antimicrobial Effectiveness Test.
Class II · Moderate risk
Well at Walgreens Regular Strength Comfort Gel Cherry Flavor
Products failed the Antimicrobial Effectiveness Test
Class II · Moderate risk
Well at Walgreens Maximum Strength Comfort Gel 12 FL OZ
Products failed the Antimicrobial Effectiveness Test
Class II · Moderate risk
"Well at Wallgreens" Regular Strength Antacid Liquid
Microbial Contamination of Non-Sterile Products: Lot in question had an elevated microbial count outside of specifications and E. Coli contamination.
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