Medication Monitor

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  • August 21, 2019

    FDA is warning consumers not to purchase or drink Miracle Mineral Solution products sold online as a remedy for autism, cancer, HIV/AIDS, hepatitis and flu, among other conditions. The solution, when mixed, develops into a dangerous bleach that has caused serious and potentially life-threatening adverse effects.

    Since 2010, FDA has warned consumers about the dangers of Miracle or Master Mineral Solution, Miracle Mineral Supplement, MMS, Chlorine Dioxide Protocol, Water Purification Solution, and similar products. FDA recently received new reports of people experiencing severe vomiting, severe diarrhea, life-threatening low blood pressure caused by dehydration, and acute liver failure after drinking these products.

    FDA is not aware of any scientific evidence supporting the safety or effectiveness of MMS products, despite claims that the solution is an antimicrobial, antiviral, and antibacterial, and the products are approved by FDA for any use.

    Websites selling MMS describe the product as a liquid that is 28% sodium chlorite in distilled water. Product directions instruct consumers to mix the sodium chlorite solution with citric acid—such as lemon or lime juice—or another acid before drinking. In many instances, the sodium chlorite is sold with a citric acid “activator.” When the acid is added, the mixture becomes chlorine dioxide, a powerful bleaching agent.

    Consumers who have experienced an adverse health effect after ingesting this product should seek immediate medical attention. Anyone who has experienced an adverse health effect that may be related to MMS should report it through the FDA’s MedWatch Safety Information program as soon as possible at 800-FDA-1088 or

  • August 21, 2019

    Pfizer is voluntarily recalling eletriptan hydrobromide 40-mg tablets, lots AR5407 and CD4565, to the patient level because these product lots may not meet Pfizer’s in-house microbiological specification for the potential presence of Genus Pseudomonas and Burkholderia.

    Individuals who consume oral products contaminated with microorganisms are at risk of bacterial dissemination from the gut to the bloodstream, potentially resulting in serious, life-threatening infections. In addition, there is risk of temporary GI distress without serious infection. For the general population these risks are low; for certain vulnerable patient populations (such as patients with compromised immune systems, cystic fibrosis, and chronic granulomatous disease), there may be the potential for serious adverse events, including life-threatening infections. 

    The 40-mg tablets are packaged in cartons. The affected lots were distributed nationwide to wholesalers, retailers, hospitals, and health care providers in the United States and Puerto Rico from June 2019 to July 2019.

    To date, Pfizer has not received any customer complaints or reports of adverse events related to this issue.

  • August 1, 2019

    On July 15, Legacy Pharmaceutical expanded its consumer-level recall of three repackaged lots of losartan tablets 50 mg (NDC 68645-494-54) to include one additional lot. This recall was prompted by Torrent Pharmaceuticals's nationwide recall of losartan tablets, which were found to contain trace amounts of N-nitroso N-methyl 4-amino butyric acid (NMBA), a potential human carcinogen. 

    The product is used to treat high blood pressure and congestive heart failure and is packaged in 30-count bottles.

    The affected losartan includes four repackaged lots numbers (three initial repackaged lots and one expanded repackaged lot): 180190, 180191, 181597, and 181598.

    To date, Legacy has not received any reports of adverse events related to this recall.

  • August 1, 2019

    On July 23, Jubilant Cadista Pharmaceuticals announced a recall of one lot (#183222) of drospirenone and ethinyl estradiol tablets, USP, 3 mg/ 0.02 mg, 28 x 3 blister pack/carton to the consumer level. The affected product is being recalled because of out-of-specification (OOS) dissolution results at the 3-month stability time point. OOS dissolution may decrease product efficacy.

    The recalled product is packaged in a carton with three blister cards, each containing 28-film coated, biconvex tablets, in the following order: 24 active pink, round, unscored, film-coated tablets debossed with a “20” on one side, each containing 3 mg drospirenone and 0.02 mg ethinyl estradiol,  and four inert white, round, unscored, film-coated tablets debossed with a “PL.”

    To date, Jubilant Cadista Pharmaceuticals has not received any reports of adverse events related to this recall.

  • August 1, 2019

    On July 15, Alvogen announced a recall of two lots (#180060 and #180073) of Fentanyl Transdermal System 12 mcg/h transdermal patches because a small number of cartons contained 50 mcg/h patches. The 50 mcg/h patches that were included in cartons labeled 12 mcg/h are individually labeled as 50 mcg/h. This transdermal system is manufactured by 3M Drug Delivery Systems, St. Paul, MN.

    Application of a 50 mcg/h patch instead of a prescribed 12 mcg/h patch could result in serious, life-threatening, or fatal respiratory depression. Groups at potential increased risk could include first-time recipients of such patches, children, and older adults. To date, Alvogen has not received any reports of adverse events related to this issue.

    The product is indicated for management of pain in opioid-tolerant patients and is packaged in primary cartons of five individually wrapped and labeled pouches.