Class I — High risk. Reasonable probability of serious harm or death.
Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."
robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10.
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 Lack of Assurance of Sterility: Media fill with bacterial contamination
Reason Presence of Particulate Matter
Reason Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Reason Lack of sterility assurance.
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