Class III · Low risk
HYDROmorphone HCl in 0.9% Sodium Chloride Injection
Labeling: Incorrect or Missing Lot and/or Exp. Date
FDA Drug Recalls
165 recalls · Class III, newest first
Class III · Low risk
morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL
Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk
Esterified Estrogens & Methyltestosterone Tablets
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Class III · Low risk
Esterified Estrogens & Methyltestosterone Tablets
Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Class III · Low risk
Ampicillin for Injection
Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Class III · Low risk
Carbamazepine Oral Suspension USP
Subpotent Drug: low out of specification results.
Class III · Low risk
Mobic (meloxicam)
Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.
Class III · Low risk
Fluocinonide Gel USP
Cross contamination with other products: traces of Dapsone were found in the finished product.
Class III · Low risk
Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz.
Failed Stability Specifications
Class III · Low risk
Magnesium Citrate Oral Solution Cherry Flavor
Failed Impurities/Degradation Specifications.
Class III · Low risk
Magnesium Citrate Oral Solution Lemon Flavor
Failed Impurities/Degradation Specifications.
Class III · Low risk
AndroGel (testosterone gel)
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class III · Low risk
AndroGel (testosterone gel)
Temperature Abuse: Prolonged exposure to temperatures outside of labeled storage conditions.
Class III · Low risk
Phentermine
Failed Impurities/Degradation Specification; out-of-specification results for individual unknown impurities at the 30 month Room Temperature Retained Sample stability test
Class III · Low risk
ENALAPRIL MALEATE Tablets
Failed Impurities/Degradation Specifications: manufacturer of product recalled this repackaged lot due to out of specification results for related compound.
Class III · Low risk
Enalapril Maleate Tablets
Failed Stability Specifications
Class III · Low risk
Propafenone Hydrochloride tablets
Failed moisture limits: Out of specification for moisture content.
Class III · Low risk
Enalapril Maleate tablets
Failed Impurities/Degradation Specifications: 5mg strength being recalled for out of specification results for related compound.
Class III · Low risk
Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Class III · Low risk
Phentermine Capsules
Failed Impurities/Degradation Specifications:Out of specification results for individual unknown impurities at 30th month Room Temperature Retained Sample stabilities test .
Class III · Low risk
Quillivant XR methylphenidate HCl
Failed Dissolution Specifications
Class III · Low risk
Quillivant XR methylphenidate HCl
Failed Dissolution Specifications
Class III · Low risk
Phentermine HCL Capsules
Failed Impurities/Degradation Specifications: out-of-specification results obtained for individual unknown impurities found at 30 month Room Temperature Retained Sample stability test.
Class III · Low risk
Glipizide Extended-Release Tablets
Failed Moisture Limits: out of specification test results for water content obtained during stability testing.