Class I · High risk
Advil Liqui Gels
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Gaviscon Regular Strength Liquid Antacid Cool Mint
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label lacks warning - Magnesium safety warning is not present on the Gaviscon bottle label.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Gaviscon Regular Strength Liquid Antacid Cool Mint, 12 FL OZ (355 mL), Distributed by: GSK Consumer Healthcare Warren, NJ 07059, NDC 0135-0094-41
Affected NDC
0135-0094-41
Compare with the code on your package — it is the most precise check available.
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 |
|---|---|---|---|---|
| Gaviscon aluminum hydroxide and magnesium carbonate NDC 00135-0094 |
ALUMINUM HYDROXIDE 95 mg/15mL; MAGNESIUM CARBONATE 358 mg/15mL | Liquid Oral |
Haleon US Holdings LLC | OTC |
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings
- NDC code
- 0135-0094-41
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1323-2020 · 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 recalls by Glaxosmithkline Consumer Healthcare Holdings
All 2020 recalls
Class I · High risk
Advil Liqui Gels
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class I · High risk
Advil (ibuprofen)
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Class II · Moderate risk
TUMS Antacid
Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool.
Other labeling / mix-up recalls from 2020
All labeling / mix-up recalls
Class II · Moderate risk
Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz
Labeling: Missing instructions for use insert
Class III · Low risk
Epinephrine/Lidocaine HCl
Labeling: Incorrect or Missing Lot and/or Exp Date
Class III · Low risk
Succinylcholine Chloride PF Inj. 200 mg/10 mL
Labeling: Incorrect or Missing lot and/or expiration date: The lot number and BUD were printed in the incorrect position on the product label making it illegible.
Class III · Low risk
Neostigmine Methylsulfate PF Inj. 5 mg/5 mL
Labelling: Missing label.
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