Class III · Low risk
Eptifibatide Injection
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
FDA Drug Recalls
152 recalls · Class III, newest first
Class III · Low risk
Eptifibatide Injection
Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class III · Low risk
Eptifibatide Injection
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Class III · Low risk
Simvastatin Tablets
Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054B instead of 05318034B
Class III · Low risk
Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count
Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergonovine Maleate tablets
Class III · Low risk
Nystatin and Triamcinolone Acetonide Cream USP100
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
Class III · Low risk
Gatifloxacin Ophthalmic Solution 0.5%
Labeling: Missing label; Product complaints reported missing bottle label.
Class III · Low risk
Smart Sense Regular Strength Aspirin Tablets
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
Lotemax (loteprednol etabonate ophthalmic gel 0.5%)
Failed Stability Specifications: Out of specification for viscosity.
Class III · Low risk
Testosterone Topical Solution 30mg of testosterone per pump…
Defective Container; actuator may improperly function and affect dose delivery.
Class III · Low risk
Myorisan (isotretinoin capsules, USP)
Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primary carton is label correctly.
Class III · Low risk
Ondansetron Injection
Failed Impurities/Degradation Specifications.
Class III · Low risk
Betamethasone Dipropionate Ointment USP
Failed Impurities/Degradation Specifications
Class III · Low risk
QUIK-CARE Aerosol Foam Hand Sanitizer
Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.
Class III · Low risk
Relpax (eletriptan HBr)
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
Dermoplast Anesthetic PAIN & ITCH
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
Dermoplast Anesthetic PAIN & ITCH
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
Fentanyl Citrate Injection
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
Carvedilol Tablets
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
Morphine Sulfate Extended-Release Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Morphine Sulfate Extended-Release Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Morphine Sulfate Extended-Release Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Morphine Sulfate Extended-Release Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Morphine Sulfate Extended-Release Tablets
Failed Impurities/Degradation Specifications
Class III · Low risk
Telmisartan and Amlodipine Tablets 80 mg/5 mg
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)