Extended-Release Metformin Recalls

The FDA has announced the recall of seven formulations of extended-release Metformin because of contamination by the carcinogen MDNA.  The recalls include:

FDA Updates Toxin Sanitizer Warning

The FDA is reporting an increase in toxic (methanol-containing) hand sanitizers and their negative consequences, including cases of blindness and death.  Find their update at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-consumers-should-not-use.

Toxic Waters

Now that high summer and higher temperatures have arrived, Harmful Algae Blooms (“HABs”) are an increasing threat to recreational and subsistence uses of bodies of fresh- and salt-water.  HABs can impact, sometimes fatally, harvesting of water- and shoreline-dwelling animals and plants, drinking, swimming, wading, and boating.  Pets and children are particularly vulnerable because they can rush into water before you even realize they’re out of the car.  The Oregon Health Authority advises,

“Don’t go into water that looks foamy, scummy, thick like paint, pea-green, blue-green or brownish red.  A good rule of thumb for you and your pet is: When in Doubt, Stay Out!”  (https://www.oregon.gov/OHA/PH/HealthyEnvironments/Recreation/HarmfulAlgaeBlooms/pages/index.aspx).

Bear in mind that most waters are not monitored for toxicity, so the lack of a warning sign is not enough to assure safe use.  The following websites provide information on identifying and responding to toxic waters and their impacts, and include alerts on the few, most popular, waters that are monitored and posted:

The Washington website is also available in Spanish, Somali, and Viet.  As an example of a posted warning, Odell Lake near Willamette Pass, between Eugene and Klamath Falls OR, has recently been posted; see the Oregon website above.

CDC HAN and FDA Warning re Hand Sanitizers

CDC has issued an HAN Health Advisory urging avoidance of Methanol-based hand sanitizers.  Methanol can cause blindness or death when absorbed through the skin.  CDC specifically indicates manufacturer Eskbiochem SA de CV, but the FDA lists many others (see below).  Find more details in the HAN at https://emergency.cdc.gov/han/2020/han00434.asp?deliveryName=USCDC_511-DM32445.

The FDA has found many hand sanitizers that are not labeled to contain Methanol but which testing has shown to be contaminated.  They have recently updated their Warning to include many other manufacturers and brands, all from Mexico.  Additional manufacturers include Grupo Insoma S.A.P.I de CV, Transliquid Technologies, Soluciones Cosmeticas SA de CV, and Tropicosmeticos SA de CV.  Brand names include Mystic Shield. Bersih, Britz, All-Clean, Esk Biochem, Lavar, The Good Gel, CleanCare NoGerm, Saniderm, and additional more generic names.

The FDA Warning advises “Consumers who have been exposed to hand sanitizer containing methanol and are experiencing symptoms should seek immediate treatment for potential reversal of toxic effects of methanol poisoning. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.”  It particularly warns about accidental ingestion, which can be fatal, especially to children.

Find the updated FDA Warning at https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-hand-sanitizers-methanol.

NW18: Recall – Diasol Concentrate for Bicarb Dialysis

The FDA has announced a Class II recall of 212 cases of Diasol 1000225-10-DEX100 Liquid Acid Concentrate for Bicarbonate Hemodialysis, UDIs B467100225101004 and B4671000225101004, Lot PHQ03041/030920, because of mislabeling.  They were distributed in California.  For details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=181559.

Recall: Baxter/Gambro HD Blood Sets

The FDA has announced the Class II recall of the following Baxter/Gambro HD Cartridge blood sets because of potential for tubing disconnection:

Recall: Bard BD WAVELINQ 4F EndoAVF System

The FDA has announced a Class II recall of one lot of the Bard Peripheral Vascular BD WAVELINQ 4F EndoAVF System, Arterial Catheter 50 cm, Venous Catheter 43 cm, Sterile EO, Rx only, Ref W04200, Lot S0053, UDI (01)00801741182754(17)210215(10)S0053 because of a magnetic deficiency that may delay or prevent formation of a functioning fistula.  For details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=179704.

CDC HAN on Chloroquine as Seen on TV

CDC has released a new HAN Health Alert Advisory on Severe Illness Associated with Using Non-Pharmaceutical Chloroquine Phosphate to Prevent and Treat COVID-19.  The Summary includes “Chloroquine phosphate, when used without a prescription and supervision of a healthcare provider, can cause serious health consequences, including death.  Clinicians and public health officials should discourage the public from misusing non-pharmaceutical chloroquine phosphate (a chemical used in home aquariums).  Clinicians should advise patients and the public that chloroquine, and the related compound hydroxychloroquine, should be used only under the supervision of a healthcare provider as prescribed medications.”  Find the CDC HAN at https://emergency.cdc.gov/han/2020/han00431.asp?deliveryName=USCDC_511-DM24285.

Recall: Revaclear Capillary Dialyzer 300

The FDA has announced the Class II recall of ten lots of the Revaclear Capillary Dialyzer 300, product code 114745L, UDI 07332414123055, because of possible particulate matter inclusions.  Lot Numbers are C419124901, C419125001, C419125101, C419125201, C419125401, C419125501, C419125601, C419125801, C419126001, and C419126401.  For full details see https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=178095.

Recall: Baxter AKI Prismaflex Control Unit

The FDA has announced Class II recalls of Baxter Prismaflex Control Units for AKI Recovery (https://www.baxter.com/healthcare-professionals/critical-care/prismaflex-system-critical-care) with software versions below 7.21 because of communication errors that may interrupt or delay therapy or result in blood loss.  Product Codes and Lot Numbers recalled include: