Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; HYDROCORTISONE Tablet, 5 mg may be potentially mislabeled as ORPHENADRINE CITRATE ER, Tablet, 100 mg, NDC 43386048024, Pedigree: W002962, EXP: 6/11/2014; CALCIUM ACETATE, Capsule, 667 mg, NDC 00054008826, Pedigree: W003045, EXP: 6/12/2014.
HYDROCORTISONE Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64720033105
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 CGMP Deviations; deficiencies observed during FDA inspection
Reason CGMP Deviations; deficiencies observed during FDA inspection
Reason Subpotent Drug
Reason Subpotent Drug
Reason Subpotent Drug
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