
FDA•LOW
Pediatric PN TPN Bags
Central Admixture recalls pediatric TPN bags due to incorrect formulation.

Central Admixture recalls pediatric TPN bags due to incorrect formulation.

Rhode Island Blood Center recalls Red Blood Cells, Leukocytes Reduced units from a malaria-endemic-area donor.

Red Cross recalls Apheresis Platelets, PAS, Leukocytes Reduced, Pathogen Reduced units lacking required yield testing.

Aurobindo recalls Dicyclomine HCl 10mg capsules due to shortfill and empty capsules.

American Regent recalls Adequan injections due to particulate matter including glass.
2 products
Parnell recalls Sevoflurane 250 mL for dogs due to incompatible bottle notch pattern.

Glenmark recalls Azelaic Acid Gel 15% over grainy/gritty texture complaints.

Micro Labs recalls Dorzolamide HCl/Timolol Maleate 2%/0.5% 10mL ophthalmic solution due to defective container caps.

Pegasus recalls Proin ER 145 mg dog tablets over failed dissolution specs.

Ascend recalls Dabigatran Etexilate 75mg/150mg capsules over impurity spec failures.
6 products
Mylan recalls Mycophenolate Mofetil for Injection 500 mg/vial due to precipitate.
2 products
Fresenius Kabi recalls injectables due to hair particulate matter.
5 products
Rohto Cooling Eye Drops recalled over sterility concerns; multiple formulations affected.
8 products
Precision Dose recalls Glycopyrrolate Oral Solution 1 mg/5 mL over an impurity.
3 products
ThermoGenesis recalls AXP Processing Bag Set, Model 8-5101, over stopcock particulates in sterile fluid path.

Lidolog Kit is being recalled because the label wrap obscures the barcode, making it difficult to scan.
2 products
Rising Pharma recalls Cyproheptadine HCl Syrup 2mg/5 mL due to crystallization and floating particles.

Major Pharmaceuticals recalls Levothyroxine 25 mcg tablets due to subpotency.
12 products
Ascend Laboratories is recalling Amlodipine and Olmesartan Medoxomil Tablets (10 mg/20 mg) due to failed dissolution specifications.

Supernus recalls Trokendi XR 25mg capsules over failed dissolution specs.
3 products
Ascend recalls Dabigatran etexilate capsules (110 mg, 150 mg) over impurity test failures.
2 products
Bionpharma recalls Divalproex Sodium 500 mg tablets due to foreign tablets/capsules.

LifeSouth is recalling Apheresis Platelets, Leukocytes Reduced, Irradiated, due to failure to meet platelet yield specifications.

CareFusion is recalling BD ChloraPrep Clear sterile solution applicators due to a potential lack of sterility from incomplete packaging seals.

Chiesi USA is recalling Cleviprex (clevidipine injectable emulsion) 50 mg/100 mL vials due to a lack of assurance of sterility.

Bell Pharmaceuticals recalls carbamide peroxide 6.5% earwax removers (CVS Health, Clinere, TopCare, etc.) for subpotency.
11 products
Padagis is recalling 15 g tubes of Nystatin Cream USP due to subpotent drug results found during stability testing.

Somerset Therapeutics recalls Pemetrexed for Injection 100mg/Vial due to cGMP deviations.
4 products
Gasco recalls Isopropyl Alcohol 70% in multiple sizes due to subpotency, which may reduce antiseptic effectiveness.
6 products
Vitalant is recalling Apheresis Platelets, Leukocytes Reduced, Irradiated due to missing white blood cell count verification testing.

QuVa Pharma is recalling Methohexital Sodium 100 mg/10 mL vials due to failed impurities and degradation specifications.

Medline Remedy Specialized Silicone Cream is recalled due to an out-of-specification result for formaldehyde in the raw material.

Shimoga Chemicals is recalling Clomiphene Citrate USP Active Pharmaceutical Ingredient due to cGMP deviations.

Avet Pharmaceuticals is recalling Methohexital Sodium for Injection 500 mg vials due to failed impurities and degradation specifications.

Cipla recalls Cinacalcet HCl 30 mg tablets due to nitrosamine impurity above ADI.
3 products
Lannett is recalling 5 mg Dextroamphetamine/Amphetamine ER capsules due to a labeling mix-up where capsules contain immediate-release pellets.

Asclemed recalls Accucaine kits and Lidocaine HCl Injection USP, 1% (10 mg/mL), 5 mL ampules due to lack of sterility assurance.
2 products
Lupin recalls Glucagon Emergency Kits due to a stability test failure that may impair emergency use.
3 products
Hikma is recalling Gemcitabine Injection due to improper temperature storage.

Boehringer Ingelheim is recalling Synjardy XR tablets due to manufacturing deviations involving improper cleaning and sampling of production equipment.

Accord Healthcare is recalling 300 mcg Levothyroxine Sodium Tablets due to subpotency.

Lupin Pharmaceuticals is recalling three sizes of prednisoLONE Acetate Ophthalmic Suspension 1% due to the presence of a foreign substance.

Ohm Laboratories is recalling 180 mg Fexofenadine Hydrochloride tablets due to failed impurities and degradation specifications.

Accord BioPharma is recalling Imuldosa (ustekinumab-srlf) 130 mg/26 mL injection vials due to a lack of assurance of sterility.

Elevate Oral Care is recalling Povi-One 10% Povidone-Iodine Oral Antiseptic due to sub-potency.

Central Admixture Pharmacy Services is recalling a pediatric TPN bag due to an incorrect formulation missing copper and famotidine.

Sun Pharmaceutical is recalling 6mg Perampanel CIII tablets due to a labeling mix-up where bottles may contain 10mg tablets.

Camber Pharmaceuticals is recalling Lacosamide 100mg tablets due to a potential mix-up with Selexipag 1000 mcg tablets.
2 products
ANI Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution, 10 mg/5 mL, due to the presence of a foreign substance.

PReye is recalling Vitamin See Antioxidant Preservative Free Eye Drops due to a lack of assurance of sterility.
