Safety Alerts & Recalls

What does this mean?

If you are taking oxycodone (which has several brand names such as Oxcontin, Roxicodone, and OxyIR), look at your prescription to see if it is labeled with the generic name "Oxycodone HCl IR 5 mg Tablets" or "Oxycodone HCl IR Tablets" (5mg, 10mg, 15mg, 20mg, or 30mg) and if it was manufactured by ETHEX Corporation. The manufacturer is often listed on the prescription label. If you are taking oxycodone immediate release and think your tablets or capsules 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 oxycodone, please follow up with your doctor or pharmacist.

Recall on All ETHEX Brand Oxycodone Tablets and Capsules

The ETHEX Corporation, a subsidiary of KV Pharmaceutical, has recalled ALL lots of ETHEX brand oxycodone immediate release tablets and capsules. These recalled tablets and capsules 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 capsules and the NDC numbers involved in the recall are listed below. The NDC number is a product number that is sometimes listed on a prescription label.

Oxycodone HCl IR Tablets, 5mg (NDC 58177-625-04 & NDC 58177-625-11)

Oxycodone HCl IR Tablets, 10mg (NDC 58177-461-04)

Oxycodone HCl IR Tablets, 15mg, (NDC 58177-445-04)

Oxycodone HCl IR Tablets, 20mg (NDC 58177-462-04)

Oxycodone HCl IR Tablets, 30mg (NDC 58177-446-04)

Oxycodone HCl Capsules, 5mg (NDC 58177-041-04 & NDC 58177-041-11)

For more information, please visit: more information here

Source: Manufacturer
Publication Date: 2009-01-29
Last Updated: 2009-12-05

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