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Safety Alert: Isosorbide
Recall on All ETHEX Brand Isosorbide Mononitrate ER Tablets
What does this mean?
If you are taking isosorbide, look at your prescription to see if it is labeled with the generic name "Isosorbide Mononitrate ER" (30mg, 60mg, or 120mg tablets) and if it was manufactured by ETHEX Corporation. The manufacturer is often listed on the prescription label. If you are taking Isosorbide Mononitrate ER and think your tablets are involved in the recall, or if you are unsure, take your bottle to your pharmacy for your pharmacist to check. Most pharmacies will provide you with replacement medicine if your medicine is involved in the recall and you return your original bottle.
At this time, this recall has not been associated with any health problems. If you are using medicine covered by this recall you should continue to take it as directed until you speak with your pharmacist - suddenly stopping your medicine may place you at a greater risk for problems.
If you have any questions or concerns about this alert or your isosorbide, please follow up with your doctor or pharmacist.
The ETHEX Corporation, a subsidiary of KV Pharmaceutical, has recalled ALL lots of ETHEX brand isosorbide mononitrate extended release tablets. These recalled tablets may have been manufactured under conditions that did not meet the current manufacturing standards called Good Manufacturing Practices (cGMPs). Some ETHEX products have recently had specific lots recalled due to defects found, including oversized tablets. ETHEX is now recalling all of their products to ensure that no other defective products remain available to patients.
The ETHEX tablets and their NDC numbers involved in the recall are listed below. The NDC number is a product number that is sometimes listed on a prescription label.
Isosorbide Mononitrate ER Tablets, 30mg (NDC 58177-222-04, NDC 58177-222-08 & NDC 58177-222-11)
Isosorbide Mononitrate ER Tablets, 60mg (NDC 58177-238-04, NDC 58177-238-08 & NDC 58177-238-11)
Isosorbide Mononitrate ER Tablets, 120mg (NDC 58177-201-04)
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