Adverse Events and Recalls

The company is recalling 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL) because of glass found in product.

A federal court ordered Guardian Pharmacy Services to stop producing compounded drugs.

The agency prioritized the review of the generic angiotensin II receptor blocker to help relieve the shortage of valsartan due to recent recalls.

The company is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP because of the possibility they may contain defective blister packs and incorrect tablet arrangements.

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg after NDEA is found in finished product manufactured with API made by Hetero Labs Limited.

The US District Court for the Western District of Pennsylvania entered into a consent decree of permanent injunction against Ranier’s Rx Laboratory Inc., a compounding facility.

The agency is requiring companies that make sartan blood pressure drugs to review their manufacturing processes due to the problem with impurities.

The company is recalling three additional lots of Ibuprofen Oral Suspension Drops, USP, 50 mg per 1.25 mL because of a higher concentration of ibuprofen.

The investigation into the root cause of the NDMA impurity found in API is still ongoing, but the agency believes the impurities may be caused by specific chemicals and reaction conditions in manufacturing processes.

The company is voluntarily recalling six lots of Losartan potassium and hydrochlorothiazide tablets, USP because of the impurity, NDEA.

Sun Pharmaceutical Industries, Inc. is recalling lots of Vecuronium Bromide for Injection because of glass particulates.

The company is recalling 5 lots of Ceftriaxone for Injection, USP, 250mg; 10 lots of Ceftriaxone for Injection, USP, 500mg; 24 lots of Ceftriaxone for Injection, USP, 1g; and 3 lots of Ceftriaxone for Injection, USP 2g because of the presence of particulate matter in reconstituted vials.

Aurobindo Pharma USA, Inc. voluntarily recalled 80 lots of Amlodipine Valsartan Tablets USP, Valsartan HCTZ Tablets, USP, and Valsartan Tablets USP because of N-nitrosodiethylamine (NDEA) in the final drug product.

FDA sent a warning letter to Roche’s Genetech for marketing unapproved stem cell products and puts other stem cell firms and providers on notice.

Asclemed USA Inc., dba Enovachem Pharmaceuticals is recalling the product due to labeling that incorrectly states that stoppers do not contain latex.

FDA has issued a warning letter to Mylan citing GMP violations of finished pharmaceutical products manufactured at the company’s Morgantown, WV, facility.

After a review of serious side effects, the agency decided to suspend marketing authorizations for quinolone and fluoroquinolone antibiotics and restrict use of remaining fluoroquinolone antibiotics.

Investigatory work arranged by Swissmedic has revealed that sartan-containing medicines on the Swiss market are safe in respect of NDMA.

Promise Pharmacy recalls one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3mL vials due to particulates in the solution.

The agency announced that differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.

The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.

FDA testing has found an additional impurity, N-Nitrosodiethylamine, in the API valsartan.

FDA is revising its inspection process and seeks harmonization of standards for US and foreign regulatory oversight to ensure the safety of medicines.

A wave of potentially impure drugs and APIs from China, India, and other foreign firms has prompted recalls and FDA warning letters.

The company is voluntarily recalling one lot of Hydrochlorothiazide Tablets USP 12.5 Mg because of a labeling mix-up.

Pfizer Consumer Healthcare is recalling one lot of Children’s Advil Suspension Bubble Gum Flavored 4 FL OZ Bottle because of improperly marked dosage cups.

King Bio is recalling several of its kids and infant products due to possible microbial contamination.

Westminster Pharmaceuticals, LLC is voluntarily recalling Levothyroxine and Liothyronine after FDA issues import alert affecting the active ingredient.

The agency issued a warning letter to Canadian API manufacturer, Les Produits Chimiques B.G.R, citing cGMP violations at its API facility in Pointe-Claire, Quebec.

AuroMedics Pharma issued a voluntary, nationwide recall of two lots of piperacillin and tazobactam for injection, USP 3.375 g due to the presence of particulates identified as glass and silicone material.