Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polysorbate 80 0.2%), Sterile, 0.4 FL OZ (13 mL) each…
Reason Lack of Assurance of Sterility
BENZOCAINE/MENTHOL, Lozenge, 15 mg/2.6 mg, Rx only, Distributed by: AidaPak Service, LLC…
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling:Label Mixup; BENZOCAINE/MENTHOL Lozenge, 15 mg/2.6 mg may be potentially mislabeled as CHOLECALCIFEROL/ CALCIUM/ PHOSPHORUS, Tablet, 120 units/105 mg/81 mg, NDC 64980015001, Pedigree: AD32345_1, EXP: 5/14/2014.
What was recalled
BENZOCAINE/MENTHOL, Lozenge, 15 mg/2.6 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 63824073116
- Recalling firm
- Aidapak Services, LLC
- Origin
- WA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-686-2014
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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Class II · Moderate risk Ongoing
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Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Sterile, 0.34 FL OZ (10 mL), Distributed by: The…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.05%), Sterile, 0.4 FL OZ (13 mL), Distributed by…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone 0.5%, propylene glycol 0.2%), Sterile, 0.4 FL OZ…
Reason Lack of Assurance of Sterility
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