Methocarbamol Injection
Presence of Particulate Matter
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Lack of Assurance of Sterility: Media fill with bacterial contamination
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
Methocarbamol Injection USP 1,000 mg/10 mL (100 mg/mL), 10 mL Single Dose Vial, Rx Only, Manufactured for: Somerset Therapeutics, LLC, Somerset, NJ 08873, NDC 70069-101-25 (immediate carton) and 70069-101-05 (5x10 mL carton)
Compare with the code on your package — it is the most precise check available.
Drug: Methocarbamol
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Methocarbamol NDC 70069-0101 |
100 mg/mL | Injection Intramuscular|intravenous |
Somerset Therapeutics, LLC | Rx |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Presence of Particulate Matter
Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actually contain Methocarbamol 750 mg Tablets
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lack of sterility assurance.
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."
Lack of Assurance of Sterility: Media fill with bacterial contamination
Lack of Assurance of Sterility: Media fill with bacterial contamination
Lack of Assurance of Sterility: Media fill with bacterial contamination
Lack of Assurance of Sterility: Media fill with bacterial contamination
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