Class II · Moderate risk Ongoing
ALOE GATOR, (Octocrylene 8%, Octyl Methoxycinnamate 6%, Benzophone 3 6%, Octyl Salicylate 5%), Original Formula, SPF 40+, Broad…
Reason Out of Specification for active ingredient
FDA Drug Recalls
411 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Bull Frog SPF 50 Amphibious Lotion SPF 50 Amphibious Lotion with Water Armor Tech, Broad Spectrum Sunscreen with UVA/UVB…
Reason Out of Specification for active ingredient
Class II · Moderate risk Ongoing
NATURAL PAIN RELIEVING CREAM, GOLDEN TIGER, (Camphor 3%, Menthol 3%) Enriched with Capsaicin, Aloe Vera, Willow Bark & MSM…
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Pain Wizard, Natural Relief for Muscular & Arthritic Pain, (Camphor 3%, Menthol 3%), Enriched with Capsaicin, Camphor, Menthol &…
Reason Out of Specification for active ingredient. Violative grade of propylene glycol used during the manufacturing process.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured…
Reason Failed Dissolution Specifications
Class II · Moderate risk Completed
Gordofilm Wart Remover (salicylic acid 16.7% USP) packaged in 15 cc glass jars, Gordon Laboratories, Upper Darby PA 19082, NDC…
Reason cGMP Deviations
Class II · Moderate risk Ongoing
Prednisolone Sodium Phosphate-Moxifloxacin-Bromfenac Sterile Ophthalmic Solution 1%, 0.5%, 0.075%, 8mL, Compounded By: Imprimis…
Reason Subpotent Drug
Class II · Moderate risk Terminated
Eyesaline, Saline Eyewash Solution, Cartridge for Fendall 2000, Net contents: 7.9 gal per cartridge, Sperian Eye & Face…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA…
Reason Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Class II · Moderate risk Terminated
Lansoprazole Delayed-Release Capsules USP, 15 mg, Acid reducer 24 Hour, Treats Frequent Heartburn, 14 capsules per bottle…
Reason CGMP Deviations
Class II · Moderate risk Terminated
Ipratropium Bromide and Albuterol Sulfate Inhalation Solution USP, 0.5 mg & 3mg/3mL unit-dose vials, packaged in carton…
Reason Short fill: Complaints received of less fill volume in respule and few drops of liquid observed in the intact pouch.
Class II · Moderate risk Ongoing
Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured…
Reason Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability…
Class II · Moderate risk Completed
Methylergonovine Maleate Tablets, USP, 0.2mg, 12-count bottle, Rx Only, Distributed by: Amneal Pharmaceuticals, LLC, Bridgewater…
Reason Failed Dissolution Specifications
Class II · Moderate risk Ongoing
fentaNYL Citrate 2,500 mcg/50mL in Sterile Water, 50 mL CADD for Injection, IntegraDose Compounding Services, LLC, 719 Kasota Ave…
Reason Lack of Assurance of Sterility: leaking bags
Class II · Moderate risk Terminated
Lactated Ringer's Injection USP, 1000mL, EXCEL CONTAINER, Rx only, B.Braun Medical Inc., Bethlehem, PA 18018, NDC 0264-7750-00
Reason Lack of assurance of sterility: bags have the potential to leak..
Class II · Moderate risk Terminated
Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202…
Reason Subpotent Drug
Class II · Moderate risk Terminated
VCF Vaginal Contraceptive Film (nonoxynol-9, 28%), package in a carton with 9 single films, Distributed By: Apothecus…
Reason cGMP Diviations
Class II · Moderate risk Completed
Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro…
Reason CGMP Deviations
Class II · Moderate risk Ongoing
Infumorph (Preservative-free Morphine Sulfate Sterile Solution), 20 mL ampul, Rx only, Manufactured by Hikma Berkeley Heights, NJ…
Reason The filter included in the carton has an expiration date that has expired prior to the expiration date of the actual product lot.
Class II · Moderate risk Terminated
Tri-Lo-Sprintec (norgestimate and ethinyl estradiol) tablets USP - triphasic regimen, packaged in carton containing 3 Blister…
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Potassium Chloride for Injection Concentrate USP, 500 mEq/250 mL (2 mEq/mL), 250 mL Bag, Rx only, B. Braun Medical Inc…
Reason Lack of assurance of sterility: pinholes, within the blue label characters on the EXCEL bag, specifically within the dotted characters on the label…
Class II · Moderate risk Terminated
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC…
Reason Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Class II · Moderate risk Ongoing
Febuxostat Tablets 80mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141…
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Ongoing
Febuxostat Tablets 40mg, RX Only, 30 Tablets per bottle, NorthStarx, Manufactured for: Northstar Rx LLC., Memphis, TN 38141…
Reason CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
Class II · Moderate risk Completed
S.P Labs, Thyroid, USP, Rx only, For Manufacturing, Processing or Repackaging Use only, Specialty Process Labs, Phoenix, AZ, NDC…
Reason Failed Stability Specifications