Pharmaceutical Recalls

​The following drugs have been recalled. Please follow the links shown in the details of the recall below in order to get more information.

 


June 10, 2017

Bristol-Myers Squibb Voluntarily Recalls One Lot of Eliquis (apixaban) 5 mg Tablets

On June 10, Bristol-Myers Squibb announced a voluntary recall of one lot (#HN0063) of Eliquis 5 mg tablets. This lot was distributed nationwide in the U.S. to wholesalers and retail pharmacies in February 2017. Bristol-Myers Squibb is taking this precautionary measure based on a single customer complaint that a bottle labeled as Eliquis5 mg was found to contain Eliquis 2.5 mg tablets. No other lots are impacted by this recall.

 


Possible Pharmaceutical Recall

On June 8, 2017, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks. This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.
“We are facing an opioid epidemic – a public health crisis, and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said FDA Commissioner Scott Gottlieb, M.D. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”
The FDA’s decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks.
Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. In 2012, Endo replaced the original formulation of Opana ER with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting. While the product met the regulatory standards for approval, the FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company’s request to include labeling describing potentially abuse-deterrent properties for Opana ER. Now, with more information about the risks of the reformulated product, the agency is taking steps to remove the reformulated Opana ER from the market.
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.”

June 8, 2017 

Mibelas 24 Fe Tablets and Professional Samples of BRILINTA Tablets Recalled
 
Lupin Pharmaceuticals, Inc, of Baltimore, MD, has voluntarily recalled one lot of Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol 1 mg/0.02 mg chewable and ferrous fumarate 75 mg) tablets. The affected product was distributed nationwide in the US to wholesalers, clinics, and retail pharmacies. The recalled lot number L600518 expires May 2018 and the National Drug Codes are 68180-911-11 (wallet of 28 tablets) and 68180-911-13 (carton of three wallets). As noted in the safety alert, a confirmed market complaint indicated a packaging error, where the blister was rotated 180 degrees within the wallet, reversing the weekly tablet orientation and making the lot number and expiration date no longer visible. The first four days of therapy would have four non-hormonal placebo tablets as opposed to the active tablets. To date, no adverse events have been reported. 

AstraZeneca voluntarily recalled one lot of professional (physician) sample bottles containing eight tablets of BRILINTA® (ticagrelor) 90 mg tablets. The product was distributed to physicians in the US between March and April 2017. The recall affects lot number JB5047. As indicated in the safety alert, the recall follows a report that a professional sample bottle containing eight tablets of BRILINTA 90 mg also contained another medicine called ZURAMPIC® (lesinurad) 200 mg tablets, which is also manufactured by AstraZeneca. To date, AstraZeneca has not received any reports of adverse events related to this recall. 

Adverse events or quality problems experienced with the use of these products may be reported to FDA’s MedWatch Adverse Event Reporting program.

Product Photos

  • Brilinta 90mg
  • Zurampic 200mg