Class II · Moderate risk
HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill…
Lack Of Assurance Of Sterility.
FDA Drug Recalls
1,134 recalls, newest first
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.
Class II · Moderate risk
Midazolam HCL 100 mg
Lack of Assurance of Sterility.
Class II · Moderate risk
Magnesium sulfate 10 Gm added to Lactated Ringer's 250 mL bags
Lack of Assurance of Sterility.
Class II · Moderate risk
Hydromorphone HCl 10 mg
Lack of Assurance of Sterility.
Class II · Moderate risk
fentanyl citrate
Lack of Assurance of Sterility.
Class II · Moderate risk
fentaNYL citrate 1000 mcg
Lack of Assurance of Sterility.
Class II · Moderate risk
ePHEDrine sulfate 50 mg/10 ml syringes in 0.9% Sodium Chloride
Lack of Assurance of Sterility.
Class II · Moderate risk
Diltiazem HCL 125 mg added to 0.9% Sodium Chloride 100 ml bag
Lack of Assurance of Sterility.
Class II · Moderate risk
No.1 Faiza Beauty Cream Manufactured by: Poonia Brothers
Marketed Without an Approved NDA/ANDA
Class II · Moderate risk
A1 Slim
Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sibutramine, phenolphthalein, and n-desmethyl sibutramine, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall.
Class II · Moderate risk
Duloxetine Delayed-release Capsules USP
Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid.
Class II · Moderate risk
Betadine Solution Swabstick Povidone-Iodine Solution USP
Subpotent Drug: The laminate used to make the pouches was reversed such that the aluminum layer was in contact with the product causing an exothermic reaction between the free iodine and the aluminum.