Class II · Moderate risk
Methocarbamol Injection USP 1
Lack of Assurance of Sterility: Media fill with bacterial contamination
robaxin-750
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
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."
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
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.
Affected NDC
52244-0449-10
Compare with the code on your package — it is the most precise check available.
Drug: Methocarbamol
- Recalling firm
- Endo Pharmaceuticals, Inc.
- NDC code
- 52244-449-10
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0009-2019 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. 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 Endo Pharmaceuticals, Inc.
All 2018 recalls
Class I · High risk
Clonazepam Orally Disintegrating Tablets
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton reflect the correct strength of 0.25 mg.
Class II · Moderate risk
Calcitonin Salmon Nasal Spray
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
Class II · Moderate risk
Edex (alprostadil for injection)
Lack of Assurance of Sterility: Defective container resulting in the lack of sterility assurance. ok thanks
Class III · Low risk
Endocet (oxycodone and acetaminophen)
Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
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