Class III · Low risk Terminated
Gatifloxacin Ophthalmic Solution 0.5%
Reason Labeling: Missing label; Product complaints reported missing bottle label.
FDA Drug Recalls
1,709 recalls · Class III, newest first
Class III · Low risk Terminated
Smart Sense Regular Strength Aspirin Tablets
Reason Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration date of 9/2022 applied to the labeling, where the actual expiration date is 10/2021.
Class III · Low risk Terminated
Lotemax
Reason Failed Stability Specifications: Out of specification for viscosity.
Class III · Low risk Terminated
Testosterone Topical Solution 30mg of testosterone per pump…
Reason Defective Container; actuator may improperly function and affect dose delivery.
Class III · Low risk Terminated
Myorisan
Reason Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Class III · Low risk Terminated
Ondansetron Injection
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Betamethasone Dipropionate Ointment USP
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
QUIK-CARE Aerosol Foam Hand Sanitizer
Reason Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.
Class III · Low risk Terminated
Relpax
Reason Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax 40 mg Tablets, indicates that each tablet contains eletriptan hydrobromide equivalent to 20mg eletriptan, instead of 40mg, on one side of the carton.
Class III · Low risk Terminated
Dermoplast Anesthetic PAIN & ITCH
Reason Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Class III · Low risk Terminated
Dermoplast Anesthetic PAIN & ITCH
Reason Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rather than the correct net weight of 2.0 oz.
Class III · Low risk Terminated
Fentanyl Citrate Injection
Reason Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
Class III · Low risk Terminated
Carvedilol Tablets
Reason Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substance, identified as a fragmented tablet of another drug product, found mixed with tablets in a bottle of Carvedilol tablets 3.125mg.
Class III · Low risk Terminated
Morphine Sulfate Extended-Release Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Morphine Sulfate Extended-Release Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Morphine Sulfate Extended-Release Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Morphine Sulfate Extended-Release Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Morphine Sulfate Extended-Release Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Telmisartan and Amlodipine Tablets 80 mg/5 mg
Reason Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
Class III · Low risk Terminated
Remifentanil HCl active pharmaceutical ingredient
Reason Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.
Class III · Low risk Terminated
Lemon Hand Sanitizer
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
Dippin' Dots Scented Cotton Candy Antibacterial Hand Gel
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
Dippin' Dots Scented Cookies 'N Cream Antibacterial Hand Gel
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
Dippin' Dots Scented Birthday Cake Antibacterial Hand Gel
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Class III · Low risk Terminated
Dippin' Dots Scented Banana Split Antibacterial Hand Gel
Reason CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.