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FDA approves oxycodone combination drug that resists abuse

A powerful combination opioid painkiller whose euphoric effects can be rendered inactive if the drug is tampered with has been approved by the Food and Drug Administration (FDA). The drug’s formulation aligns with the agency’s commitment to combat the misuse and abuse of opioids. “The development of opioids that are harder to abuse is needed in order to help address the public health crisis of prescription drug abuse in the U.S.,” Dr. Sharon Hertz, deputy director of the division of anesthesia, analgesia, and addiction products in the FDA’s Center for Drug Evaluation and Research, said in an news release. Targiniq ... Read More

Motrin infant drops recalled due to risk of plastic particles floating in bottles

Three lots, or approximately 200,000 bottles, of Concentrated Motrin Infants’ Drops are being recalled because small bits of plastic may be floating in the bottles. The recall affects the Original Berry Flavored ½ fl oz bottles distributed in the United States. After releasing the three lots of Concentrated Motrin Infants’ Drops Original Berry Flavor ½ fl oz into the market, tiny plastic particles measuring about 1 mm – about the size of a poppy seed – were seen in a different product lot during manufacturing. This lot was not released. However, it was determined that the particles originated in a ... Read More

Johnson & Johnson recalls 32 million packs of birth control pills

Johnson & Johnson has issued another massive recall, this time on 32 million packages of birth control pills because of a flaw that could cause unplanned pregnancies. The oral contraceptives are sold in 43 countries around the world, but not in the United States. This recall is one of about 40 the consumer health product giant has issued on everything from over-the-counter medications to artificial hips since 2009. The recall was initiated because quality tests performed on the drugs showed one of the two hormones in the pills was releasing slower than it should. The company said the risk of ... Read More

More counterfeit vials of cancer drug Avastin found in US

More counterfeit versions of Roche’s best-selling cancer drug Avastin are being distributed to medical facilities in the United States, the Food and Drug Administration (FDA) warned. This is the third time in a year that federal regulators have discovered counterfeit versions of the widely used drug to treat cancers of the colon, kidneys, lungs and brain. The latest batch of counterfeit Avastin does not contain the active ingredient found in the authentic version. The latest batch of counterfeit Avastin was distributed by Medical Device King and is packaged as Altuzan, the Turkish version of Avastin, which is not approved in the ... Read More

FDA pulls Teva’s generic Wellbutrin for working improperly

Teva Pharmaceuticals has stopped shipping its generic version of Wellbutrin XL 300 after a federal analysis found the antidepressant does not work in the same way the brand name drug does. Drug regulators discovered that Teva’s generic Wellbutrin XL 300, known by the name Budeprion, releases its key ingredient faster than the brand name Wellbutrin XL 300, which is made by GlaxoSmithKline. Generic drugs are ones that are comparable to brand-name drugs in dosage, strength, route of administration, quality and performance characteristics, and intended use. Generic drugs must contain the same active ingredients as the original formulation. Both Wellbutrin XL ... Read More

Counterfeit cancer drug traced back to distributors in Egypt

Counterfeit vials of the cancer drug Avastin that were found circulating in Europe and the United States earlier this month contain salt, starch and a variety of chemicals, but none of the active ingredient bevacizumab that fights cancer. Avastin is an injectable medicine made by Swiss drug maker Roche. It is administered to patients at clinics, hospitals and doctors’ offices. It is used to treat various forms of cancer including colon, kidney, brain and lung cancers. Avastin made headlines recently when the Food and Drug Administration (FDA) pulled the drug’s breast cancer indication because it was not proven safe or ... Read More