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 SULFATE Capsule, 220 mg may be potentially mislabeled as CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: AD52778_10, EXP: 5/20/2014; CALCITRIOL, Capsule, 0.25 mcg, NDC 00054000725, Pedigree: W003638, EXP: 6/25/2014.
ZINC SULFATE Capsule, 220 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 60258013101
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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