Class II · Moderate risk
Phenylephrine Hydrochloride Injectable Solution
cGMP deviations.
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Lacks Warning or Rx Legend- Certain lots does not include required safety warning information in the Drug Facts Panel.
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
Ibuprofen 200 mg Chlorpheniramine Maleate 4mg Phenylephrine 10 mg tablets. Advil Allergy & Congestion Relief 10 and 20 count blister tray in carton NDC 0573-0196-10, item # F00573019610C, 10 ct. blister NDC 0573-0196-20, item # F00573019620C, 20 ct. blister NDC 0573-0196-10, item # F00573019610R, 10 ct. blister
Affected NDCs
0573-0196-10
0573-0196-20
Compare with the code on your package — it is the most precise check available.
Drug: Phenylephrine Category: Pain Relief & OTC Medication
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 |
|---|---|---|---|---|
| Advil Allergy and Congestion Relief chlorpheniramine maleate, ibuprofen, and phenylephrine hydrochloride NDC 00573-0196 |
CHLORPHENIRAMINE MALEATE 4 mg/1; IBUPROFEN 200 mg/1; PHENYLEPHRINE HYDROCHLORIDE 10 mg/1 | Tablet, Coated Oral |
Haleon US Holdings LLC | OTC |
- Recalling firm
- Glaxosmithkline Consumer Healthcare Holdings
- NDC code
- 0573-0196-10
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1065-2020 · 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 Phenylephrine recalls
See all
Class II · Moderate risk
Tropicamide 1%/Cyclopentolate 1%/Phenylephrine 2.5%/Ketorolac…
Incorrect Product Formulation
Class II · Moderate risk
Phenylephrine HCI
CGMP Deviations
Class III · Low risk
Tropicamide-Proparacaine-Phenylephrine-Ketorolac
Sub-Potent Drug: Subpotent assay results during stability testing.
Class II · Moderate risk
PHENYLephrine HCl in 0.9% Sodium Chloride
Lack of Assurance of Sterility: Leaking/damaged syringes.
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 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.
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