Class III · Low risk
CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials…
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Subpotent Drug
Cause type: Wrong potency / content
Sub- or super-potent product, or a failed content-uniformity / assay test. You may receive too little or too much active ingredient - a direct dosing risk. All wrong potency / content recalls.
What was recalled
CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flavor 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each 4.06 FL OZ (120 mL) Total NDC 69842-499-08 UPC 0 50428 64130 9 Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895
Affected NDC
69842-0499-08
Compare with the code on your package — it is the most precise check available.
- Recalling firm
- New Vision Pharmaceuticals LLC
- NDC code
- 69842-499-08
- Origin
- FL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0853-2021 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 New Vision Pharmaceuticals LLC
All 2021 recallsOther wrong potency / content recalls from 2021
All wrong potency / content recalls
Class II · Moderate risk
Pioglitazone Tablets USP
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Class II · Moderate risk
Penicillin V Potassium for Oral Solution
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Class III · Low risk
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000…
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
Class III · Low risk
CariFree sample boxes
Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
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