busPIRone Hydrochloride Tablets, USP, 5 mg, 500-count bottle, Rx Only, Manufactured by Unichem Laboratories LTD., Ind, Area…
Reason Subpotent drug
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: MULTIVITAMIN/MULTIMINERAL W/IRON, CHEW Tablet, 0 mg may have potentially been mislabeled as the following drug: CHOLECALCIFEROL, Capsule, 2000 units, NDC 00536379001, Pedigree: W003017, EXP: 6/12/2014.
MULTIVITAMIN/MULTIMINERAL W/IRON, CHEW Tablet, 0 mg, Over The Counter, Distributed by: AidaPak Service, LLC, NDC 00536781601.
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 Subpotent drug
Reason Presence of foreign substance: identified as aluminum.
Reason Defective Delivery System: Leakage observed after oral solution was repackaged into unit-dose syringes.
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
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