Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals…
Reason Failed Tablet/Capsule Specifications
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup; buPROPion HCl ER Tablet, 200 mg may be potentially mislabeled as AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W002726, EXP: 6/6/2014.
buPROPion HCl ER Tablet, 200 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 47335073886
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 Failed Tablet/Capsule Specifications
Reason Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Reason Presence of Foreign Tablets/Capsules
Reason Failed Dissolution Specifications
Reason Failed Dissolution Specifications
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