Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0.05%, zinc sulfate 0.25%), Sterile 0.4 FL OZ (13…
Reason Lack of Assurance of Sterility
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; ZINC GLUCONATE, Tablet, 50 mg may be potentially mis-labeled as ASCORBIC ACID, Chew Tablet, 500 mg, NDC 00904052660, Pedigree: AD60240_54, EXP: 5/22/2014 and ASCORBIC ACID, Chew Tablet, 250 mg, NDC 00904052260, Pedigree: W003027, EXP: 6/12/2014.
ZINC GLUCONATE, Tablet, 50 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904319160.
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.
Reason Lack of Assurance of Sterility
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason CGMP Deviations; deficiencies observed during FDA inspection
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