Class III · Low risk Terminated
Penicillin V Potassium for Oral Solution
Reason Failed Impurities/Degradation Specifications: high out of specification test results obtained for individual and total impurities.
FDA Drug Recalls
1,523 recalls · Class III, newest first
Class III · Low risk Terminated
Duloxetine Delayed-Release Capsules USP
Reason Failed Dissolution Specification
Class III · Low risk Terminated
Isradapine Capsules USP 2.5 mg
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Fluconazole Injection
Reason Superpotent
Class III · Low risk Terminated
Bayer Chewable Low Dose Aspirin 81 mg Orange Flavored 36 tablets
Reason Failed Stability Specifications
Class III · Low risk Terminated
Ciprofloxacin in Dextrose
Reason Superpotent
Class III · Low risk Terminated
Dexamethasone Sodium Phosphate Injection
Reason Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class III · Low risk Terminated
Dexamethasone Sodium Phosphate Injection
Reason Failed Impurities/Degradation Specifications: high out of specification results for Dexamethasone adduct (related compound).
Class III · Low risk Terminated
bupPROPion HCL Extended-Release Tablets
Reason Failed Impurities/Degradation Specifications: Mylan Pharmaceuticals Inc. is conducting a voluntary recall due to related out of specification compound results obtained during routine stability testing.
Class III · Low risk Terminated
Meclizine hydrochloride tablets USP
Reason Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Class III · Low risk Terminated
Doan's Pain Relieving Cream with 4% Lidocaine Plus Menthol
Reason Labeling: Incorrect or Missing Lot and/or Exp Date; lot number on the secondary packaging doesnt match the lot number printed on the bottle
Class III · Low risk Terminated
Lumigan
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Combigan
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Methylphenidate Hydrochloride Tablets USP
Reason Failed Dissolution Specifications: Low out of specification results for dissolution.
Class III · Low risk Terminated
Clofarabine injection
Reason Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Class III · Low risk Terminated
Clolar
Reason Labeling: Incorrect or Missing Package Insert.
Class III · Low risk Terminated
Famotidine tablets
Reason Failed impurities/degradation specifications: Famotodine has an out of specification result for an individual related substance observed during routine stability testing of a batch for related substances -impurity 8 at 24 month stability interval.
Class III · Low risk Terminated
HYDROmorphone HCl in 0.9% Sodium Chloride Injection
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk Terminated
morphine Sulfate in 0.9% Sodium Chloride Injection 1 mL Total Volume 2 mg per mL
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk Terminated
morphine Sulfate in 0.9% Sodium Chloride Injection 2 mL Total Volume 1 mg per mL
Reason Labeling: Incorrect or Missing Lot and/or Exp. Date
Class III · Low risk Terminated
Esterified Estrogens & Methyltestosterone Tablets
Reason Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Class III · Low risk Terminated
Esterified Estrogens & Methyltestosterone Tablets
Reason Subpotent Drug: Out of specification assay result in Esterified Estrogen and Methyltestosterone tablets.
Class III · Low risk Terminated
Ampicillin for Injection
Reason Labeling: Missing Label: customer complaint that some vials of ampicillin within the shrink wrap pack are missing labels.
Class III · Low risk Terminated
Carbamazepine Oral Suspension USP
Reason Subpotent Drug: low out of specification results.
Class III · Low risk Terminated
Mobic
Reason Labeling: Incorrect or missing package insert. One lot of Mobic Tablets is packaged with an incorrect insert.