Recalls That Should Be on Your Radar—Week of September 15, 2019

We’ve compiled a list of recalls issued by the US Food and Drug Administration (FDA) and US Department of Agriculture (USDA) from this past week:

Torrent Pharmaceuticals Limited Issues Recall for Losartan Products Due to NMBA

Torrent Pharmaceuticals Limited is expanding its recall for Losartan Potassium Tablets USP and Losartan Potassium / hydrochlorothiazide tablets, USP, to the consumer level due to the detection of trace amounts of an unexpected impurity while testing the below finished product batches manufactured utilizing active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited using the old Route of Synthesis. The recall is expanded to include an additional 3 lots of Losartan Potassium Tablets USP and 2 lots of Losartan Potassium/Hydrochlorothiazide Tablets, USP.

The impurity detected is N-Methylnitrosobutyric acid (NMBA). Torrent is only recalling lots of losartan-containing products that contain N-Methylnitrosobutyric acid (NMBA) above the acceptable daily intake levels released by the FDA.

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Losartan Potassium and Hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy.

Patients who are taking Losartan Potassium Tablets, USP and Losartan Potassium / Hydrochlorothiazide Tablets, USP should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

Read the full recall statement.

General Mills Issues Recall for Gold Medal Unbleached All Purpose Flour Due to E Coli Risk

General Mills announced today a voluntary national recall of five-pound bags of its Gold Medal Unbleached All Purpose Flour with a better if used by date of September 6, 2020. The recall is being issued for the potential presence of E. coli O26 which was discovered during sampling of the five-pound bag product. This recall is being issued out of an abundance of care as General Mills has not received any direct consumer reports of confirmed illnesses related to this product.

This recall only affects this one date code of Gold Medal Unbleached All Purpose Flour five-pound bags. All other types of Gold Medal Flour are not affected by this recall.

Guidance from the Food and Drug Administration (FDA) and the Centers for Disease Control (CDC) continues to warn that consumers should refrain from consuming any raw products made with flour. E. coli O26 is killed by heat through baking, frying, sautéing or boiling products made with flour. All surfaces, hands and utensils should be properly cleaned after contact with flour or dough.

Read the full recall here.

Fitoterpia USA Inc. Issues Recall for Vitamin C Supplement Due to Undeclared Tadalafil

Fitoterapia USA Inc., is voluntarily recalling 19,000 bottles of macho artificial passion fruit flavored vitamin C liquid supplement, liquid dietary supplement to the consumer level. FDA analysis has found the product to be tainted with Tadalafil. Tadalafil is an active ingredient in a FDA- approved prescription drug that is used for the treatment of male erectile dysfunction. The presence of Tadalafil in Mero Macho renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.

Consumers who take dietary supplements for erectile dysfunction could have underlying diseases such as diabetes, hypertension, or high cholesterol. Consumers with diabetes, hypertension, high cholesterol or heart disease often take nitrates; concomitant use of nitrates and phosphodiesterase 5- inhibitors can lead to fatal cardiovascular collapse. To date, Fitoterapia USA Inc. has not received any reports of adverse events related to this recall.

The tainted product is marketed as a dietary supplement for sexual enhancement and is packaged in fl oz liquid and 8.5 fl oz, per bottle. The affected lots include the following, LOT: ZD-160-18 EXP: 09-07-2019, LOT: ZD-078-19 EXP: 27-04-2020, LOT: ZD-159-17 EXP: 31-05-2018. The product can be identified as a white bottle with a high print at the bottom (fitoterapia —logo), plastic label heated sealed, each bottle with its bar code.

Read the full recall statement.