Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: VENLAFAXINE HCL ER, Capsule, 150 mg may have potentially been mislabeled as one of the following drugs: SOTALOL HCL, Tablet, 80 mg, NDC 00093106101, Pedigree: AD30993_17, EXP: 5/9/2014; CYANOCOBALAMIN, Tablet, 1000 mcg, NDC 00904421713, Pedigree: W003075, EXP: 6/12/2014; LANTHANUM CARBONATE, CHEW Tablet, 500 mg, NDC 4092025290, Pedigree: W003410, EXP: 6/19/2014.
VENLAFAXINE HCL ER, Capsule, 150 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093738656.
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 Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.
Reason Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
Reason Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Reason Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
Reason Presence of Forein Tablets/Capsules; Venlafaxine Tablets, USP 37.5 mg found in bottles labeled as Venlafaxine Tablets, USP, 50 mg
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