Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe) may be potentially mislabeled as COENZYME Q-10, Capsule, 100 mg, NDC 37205055065, Pedigree: W002711, EXP: 6/6/2014; VENLAFAXINE HCL, Tablet, 25 mg, NDC 00093019901, Pedigree: W002825, EXP: 12/31/2013; DOCUSATE SODIUM, Capsule, 250 mg, NDC 00536375710, Pedigree: AD60236_1, EXP: 5/22/2014.
FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe), Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00904759160
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 Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Failed Impurities/Degradation Specifications: Out of specification result observed in related substance test.
Reason Failed Tablet/Capsule Specifications: Complaints related to crumbling of tablets when popped out of the blister pack.
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