The FDA will be requiring several updates to the prescribing information for all opioid pain medications. All opioid pain medications will note that the risk of overdose increases as the dose increases, as well as a new warning about opioid-induced...
Teva Pharmaceuticals has voluntarily recalled specific lots of various strengths of fentanyl buccal tablets CII at the consumer level due to a labeling error. This recall has been initiated because safety updates were omitted in the Product Insert/Medication Guide (MG)...
Family Dollar initiated a recall of various Advil (ibuprofen) over-the-counter products that were stored and shipped to certain stores on or around June 1, 2022 through March 31, 2023 by Family Dollar outside of labeled temperature requirements. Exposure to high...
The FDA approved Narcan (naloxone hydrochloride) 4mg nasal spray for over-the-counter (OTC) use – the first naloxone product approved for use without a prescription. Naloxone rapidly reverses the effects of opioids and is the standard treatment for opioid overdose. As...
The FDA will soon require opioid manufacturers to make prepaid mail-back envelopes available to outpatient pharmacies and other dispensers as an additional opioid analgesic disposal option for patients. The FDA issued notice to all opioid manufacturers that they are required...
ViiV Healthcare, a GlaxoSmithKline company, communicated to the FDA that several HIV medications they manufacture will be discontinued by the end of 2023. Epzicom® (abacavir sulfate, lamivudine) 600/300mg tablets and Trizivir® (abacavir sulfate, lamivudine, zidovudine) 300mg/150mg/300mg tablets will be discontinued...
Eli Lilly, one of three insulin manufacturers in the country, announced plans to reduce list prices of insulin by 70%. Humalog 100 units/mL will be reduced in price starting in Q4 of 2023. The price of nonbranded Insulin Lispro Injection...
The FDA issued a Federal Register notice that assessed the safety and effectiveness of certain naloxone hydrochloride products for nonprescription use, hoping to make the opioid overdose reversal agent more accessible to the public. The preliminary assessment is intended to...
The FDA approved Tzield® (teplizumab-mzwv) injection, a new drug that can delay the onset of type 1 diabetes by several months or years. Type 1 diabetes occurs when the immune system attacks and destroys the cells that make insulin, requiring...
Golden State Medical Supply, Incorporated initiated a voluntary recall of Clopidogrel 75mg Tablets (lot# GS046745) and Atenolol 25mg Tablets (lot #GS046745) due to a label mix-up. Atenolol is indicated for the treatment of hypertension, to lower blood pressure, while Clopidogrel...
Aurobindo Pharma USA, Inc. has initiated a voluntary recall of two lots of Quinapril and Hydrochlorothiazide Tablets USP 20mg / 12.5mg – fixed combination tablets indicated to lower blood pressure and treat hypertension – due to presence of Nitrosamine Drug...
Vi-Jon, LLC has issued a nationwide voluntary recall for all lots of magnesium citrate saline laxative oral solution lemon flavor, 10 FL Oz (296 mL) due to microbial testing that identified the presence of gluconacetobacter liquefaciens. This microbe can be...
The FDA granted Emergency Use Authorization (EUA) to the Novavax COVID-19, Adjuvanted vaccine for individuals aged 18 and older. This vaccine is administered in two primary doses given three weeks apart. The vaccine was assessed in an ongoing randomized, blinded,...
The FDA’s Vaccines and Related Biological Products Advisory Committee voted 21-0 in favor of recommending an Emergency Use Authorization (EUA) for the Novavax COVID-19 vaccine for individuals aged 18 and older. Phase 3 clinical trials with 30,000 people saw an...
Bryant Ranch Prepack Inc. is voluntarily recalling one lot of morphine sulfate 30 mg Extended-Release tablets and one lot of morphine sulfate 60 mg Extended-Release tablets, as the labels for these two products were mixed-up. Morphine sulfate is an opioid...
