Drugs & Medicine Recalls
Pharmaceutical recall notices, chemical impurities, and biological contamination.
Sensipar (cinacalcet) Tablets, 30mg, 30-count bottles, Rx Only, Distributed by: ...
CGMP Deviations
Corlanor (ivabradine) tablets, 5 mg, packaged in a) 14 tablets bottles (NDC 5551...
Presence of Foreign Substance.
PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PReye...
Lack of Assurance of Sterility
Sensipar (cinacalcet) Tablets, 90mg, 30-count bottles, Rx Only, Distributed by: ...
CGMP Deviations
BD ChloraPrep FREPP Clear,(2% w/v chlorhexidine gluconate (CHG) and 70% v/v isop...
Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Lacosamide Tablets, USP, C V, 100mg, Rx only, 60-count bottle, By: Annora Pharma...
Presence of a Foreign Tablets: Complaint received, possible mix-up of Selexipag 1000 mcg tablet in a bottle of Lacosamide Tablets USP, 100mg.
BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v iso...
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (...
Subpotent Drug
Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Ajanta...
CGMP Deviations
Perampanel CIII Tablets, 6mg, Rx only, 30 Tablets, Mfd.by: Taro Pharmaceutical I...
Labeling: Label Mix-up: 10mg Perampanel CIII tablet was found in a Perampanel CIII bottle labeled Perampanel 6 mg tablets.
Povi-One, 10% Povidone-Iodine Oral Antiseptic, Packaged by Elevate Oral Care, LL...
sub potency
Corlanor (ivabradine) tablets, 7.5mg, 60-count bottles, Rx Only, Amgen Inc., Tho...
Presence of Foreign Substance.
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx on...
Presence of foreign substance
BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl ...
Non-Sterility: Due to presence of Aspergillus penicillioides.
Sensipar (cinacalcet) Tablets, 60mg, 30-count bottles, Rx Only, Distributed by: ...
CGMP Deviations
DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60...
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl...
Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal area.
Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient speci...
Incorrect product formulation: bag did not contain copper and famotidine per label.
Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ (30...
Defective container:may contain bottles with incomplete seals
Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30 mL...
Defective container:may contain bottles with incomplete seals
DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), Man...
Defective container:may contain bottles with incomplete seals
Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bottl...
Labeling: Incorrect or Missing Lot and/or Exp Date
Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case, Ma...
CGMP Deviations; deficiencies observed during FDA inspection
Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Flavo...
Defective container:may contain bottles with incomplete seals