Class II · Moderate risk
Methocarbamol Injection USP 1
Lack of Assurance of Sterility: Media fill with bacterial contamination
Methocarbamol 750 mg Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
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.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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.
Affected NDC
42549-0521-90
Compare with the code on your package — it is the most precise check available.
Drug: Methocarbamol
- Recalling firm
- Stat Rx USA
- NDC code
- 42549-521-90
- Origin
- GA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-144-2013 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Methocarbamol recalls
See all
Class I · High risk
Methocarbamol Injection
Presence of Particulate Matter
Class I · High risk
Methocarbamol 500mg Tablet
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
Class II · Moderate risk
Methocarbamol 500mg 500
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Methocarbamol liquid 100mg/ml
Lack of sterility assurance.
Other recalls by Stat Rx USA
All 2013 recalls
Class III · Low risk
Venlafaxine ER 150mg
Labeling: Label Mix-up: Product was incorrectly labeled,"Tabs" instead of "Capsules."
Class III · Low risk
Tizanidine
Labeling: Label Mix-Up; Some bottles of Tizanidine 4mg Tablets, had the incorrect manufacturer (Actavis) printed on the label.
Class III · Low risk
Tobramycin Ophthalmic Oint.
Labeling: Label Mix-up: The affected units were labeled incorrectly describing the product as "ointment" instead of "solution."
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