Class I · High risk
diphenoxylate hydrochloride and atropine sulfate tablets
SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
FDA Drug Recalls
18,003 recalls, newest first
Class III · Low risk
Lumigan (bimatoprost ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Combigan (brimonidine tartrate/timolol maleate ophthalmic solution)
Failed Impurities/Degradation Specifications.
Class II · Moderate risk
ROCuronium Bromide 10 mg per mL
Lack Of Assurance Of Sterility.
Class II · Moderate risk
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag
Lack Of Assurance Of Sterility.
Class II · Moderate risk
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL…
Lack Of Assurance Of Sterility.
Class II · Moderate risk
oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag
Lack Of Assurance Of Sterility.
Class II · Moderate risk
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total…
Lack Of Assurance Of Sterility.
Class II · Moderate risk
fentaNYL as citrate 2 mcg / mL
Lack Of Assurance Of Sterility.
Class II · Moderate risk
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125%
Lack Of Assurance Of Sterility.
Class II · Moderate risk
HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9% Sodium Chloride 50 mL
Lack Of Assurance Of Sterility.
Class II · Moderate risk
HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill…
Lack Of Assurance Of Sterility.
Class II · Moderate risk
SUCcinylcholine 20 mg per mL
Lack Of Assurance Of Sterility.
Class III · Low risk
Methylphenidate Hydrochloride Tablets USP
Failed Dissolution Specifications: Low out of specification results for dissolution.
Class II · Moderate risk
Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL
Superpotent drug: out of specification result for potency
Class III · Low risk
Clofarabine injection
Labeling: Incorrect or Missing Package Insert: authorized generic product was packaged with the incorrect insert for the brand name product Clolar (clofarabine) injection.
Class II · Moderate risk
Levetiracetam Oral Solution
Presence of foreign substance (screw)
Class III · Low risk
Clolar (clofarabine)
Labeling: Incorrect or Missing Package Insert.
Class II · Moderate risk
Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag
Lack of Assurance of Sterility.
Class II · Moderate risk
VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag
Lack of Assurance of Sterility.
Class II · Moderate risk
VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag
Lack of Assurance of Sterility.
Class II · Moderate risk
Succinylcholine 200 mg/10 mL Syringe
Lack of Assurance of Sterility.
Class II · Moderate risk
Ropivacaine HCL
Lack of Assurance of Sterility.
Class II · Moderate risk
OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag
Lack of Assurance of Sterility.
Class II · Moderate risk
Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag
Lack of Assurance of Sterility.