Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; ORPHENADRINE CITRATE ER Tablet, 100 mg may be potentially mislabeled as OMEGA-3 FATTY ACID, Capsule, 1000 mg, NDC 40985022921, Pedigree: W002965, EXP: 6/10/2014.
ORPHENADRINE CITRATE ER Tablet, 100 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 43386048024
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:Nitrosamine impurity (NMOA) above the acceptable daily limit.
Reason Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they…
Reason Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
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