
FDA•MODERATE
Dorzolamide HCl and Timolol Maleate Ophthalmic Solution
Micro Labs recalls Dorzolamide HCl/Timolol Maleate 2%/0.5% 10mL ophthalmic solution due to defective container caps.

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

Fresenius Kabi recalls multiple injectable drugs due to hair found in product.
5 products
Rohto-Mentholatum recalls multiple Rohto Cooling Eye Drops over sterility concerns.
8 products
ThermoGenesis recalls AXP Processing Bag Set, Model 8-5101, over stopcock particulates in sterile fluid path.

Rising Pharma recalls Cyproheptadine HCl Syrup 2mg/5 mL due to crystallization and floating particles.

Major Pharmaceuticals is recalling Levothyroxine Sodium 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.

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 store-brand carbamide peroxide ear drops for subpotency (low pH, ~0.6% assay).
11 products
Padagis is recalling 15 g tubes of Nystatin Cream USP due to subpotent drug results found during stability testing.

Reliance Life Sciences recalls Pemetrexed for Injection 100mg/Vial over cGMP deviations.
4 products
Gasco recalls Isopropyl Alcohol 70% in 16 oz, 32 oz, and 1 gal sizes due to subpotency.
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 over N-nitroso impurity above safe limit.
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 ampules over sterility concerns.
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.

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