Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Labeling: Incorrect or missing lot and/or expiration date. The product was mistakenly labeled with an expiration date of 10/16 instead of 01/16.
Methocarbamol 750 mg Tablets, 90-count bottle, Mfg by: West-Ward Pharm. Corp., Eatontown, NJ 07724, Packaged and Distributed by: Stat Rx USA, NDC 42549-521-90.
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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