It’s only Tuesday, and there have already been a handful of recalls this week. On August 9, The Food and Drug Administration announced Westminster Pharmaceuticals, LLC voluntarily recalled all lots, with an expiry of Levothyroxine and Liothyronine, common Thyroid Tablets, 15mg, 30 mg, 60, mg, 90, mg, and 120 mg to wholesale level. The tablets were recalled due to precaution after they were manufactured using active pharmaceutical ingredients, used prior to to the FDA’s Import Alert of Sichuan Friendly Pharmaceutical Co., Ltd. Experts found them to have deficiencies with Current Good Manufacturing Practices.
This morning, the FDA issued another recall of a common blood pressure medication, expanding to a separate manufacturer. Torrent Pharmaceuticals LTD is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets due to trace amounts of an impurity in an ingredient. Valsartan is usually used to control high blood pressure and treat heart failure. If combined with hydrochlorothiazide and amlodipine, is can be used to control high blood pressure.
The impurity is N-nitrosodimethylamine (say that three times, I dare you) occurs naturally in some foods, drinking water, industrial processes, and air pollution. The International Agency for Research classifies NDMA as a probable human carcinogen. According to Drug-maker Torrent Pharmaceuticals, it has not received reports of adverse events related to the recall, but since thyroid medication can treat serious diseases, patients should contact their physician or pharmacist and ask about alternative treatments or replacement products prior to returning their medication. Valsartan/Amlodipine/HCTZ tablets were distributed across the United States to Torrent’s distributors, wholesale, repackaged, and retail customers.
Any patient who is on Valsartan should continue to take it, as the risk of harm to the patient’s health may be higher if the treatment is stopped without any alternative treatment. The products subject to recall are packed in 100 count bottles, and one should look at the products NDCS, product description, lot numbers, and expiration dates. The following products have been recalled, according to the FDA:
- NDC 13668-325-30: USP 10mg/320mg/25mg, BBX2D025 – BBX2D026, EXP: Nov-2019
- NDC 13668-325-30: USP 10mg/320mg/25mg, BBX2E001- BBX2E005, EXP: Jan-2020
- NDC 13668-328-30: USP 10mg/160mg/25mg, BBX9D004, EXP: Nov-2019
- NDC 13668-328-30: USP 10mg/160mg/25mg, BBX9E001, EXP: Jan-2020
- NDC 13668-326-30: USP 5mg/160mg/12.5mg, BBY1E001, EXP: Dec-2019
- NDC 13668-326-30: USP 5mg/160mg/12.5mg, BBY1E003, EXP: Mar-2020
- NDC 13668-327-30: USP 10mg/160mg/12.5mg, BBY2E001,EXP: Mar-2020
- NDC 13668-329-30: USP 5mg/160mg/25mg, BBY4D004, EXP: Nov-2019
- NDC 13668-329-30: USP 5mg/160mg/25mg, BBY4E001, EXP: Jan- 2020
For more information you are asked to call your local doctor of pharmaceutical company for information on specific products and recall alerts.