Class II · Moderate risk Terminated
Estriol
Reason cGMP Deviations: lack of quality assurance at the API manufacturer.
FDA Drug Recalls
14,450 recalls · Class II, newest first
Class II · Moderate risk Terminated
Dutasteride and Tamsulosin HCl Capsules
Reason Failed dissolution specifications; all lots within expiry are being recalled due to out of specification dissolution results.
Class II · Moderate risk Terminated
Paroxetine Tablets
Reason Presence of Foreign Tablets/Capsules.
Class II · Moderate risk Terminated
Succinylcholine 20 MG/ML INJ
Reason Labeling: Incorrect or Missing Lot and/or Exp Date; incorrect expiration date on the labeling of the outer poly bag
Class II · Moderate risk Terminated
Zoloft
Reason SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class II · Moderate risk Terminated
ROCuronium Bromide 10 mg per mL
Reason Lack Of Assurance Of Sterility.
Class II · Moderate risk Terminated
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag
Reason Lack Of Assurance Of Sterility.
Class II · Moderate risk Terminated
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL…
Reason Lack Of Assurance Of Sterility.
Class II · Moderate risk Terminated
oxyTOCIN 30 units added to Lactated Ringers 500 mL Bag
Reason Lack Of Assurance Of Sterility.
Class II · Moderate risk Terminated
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total…
Reason Lack Of Assurance Of Sterility.
Class II · Moderate risk Terminated
fentaNYL as citrate 2 mcg / mL
Reason Lack Of Assurance Of Sterility.
Class II · Moderate risk Terminated
fentanyl as citrate 2 mcg per mL BUPIvacaine HCl 0.125%
Reason Lack Of Assurance Of Sterility.
Class II · Moderate risk Terminated
HYDROmorphone HCl 20 mcg / mL BUPIvacaine HCl 0.075% in 0.9%…
Reason Lack Of Assurance Of Sterility.
Class II · Moderate risk Terminated
HYDROmorphone HCL 1 mg per mL in 0.9% Sodium Chloride 25 mL Fill…
Reason Lack Of Assurance Of Sterility.
Class II · Moderate risk Terminated
SUCcinylcholine 20 mg per mL
Reason Lack Of Assurance Of Sterility.
Class II · Moderate risk Terminated
Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL
Reason Superpotent drug: out of specification result for potency
Class II · Moderate risk Terminated
Levetiracetam Oral Solution
Reason Presence of foreign substance (screw)
Class II · Moderate risk Terminated
Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
VANCOmycin 1.25 grams added to 0.9% Sodium Chloride 500 mL bag
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
VANCOmycin 1.5 grams added to 0.9% Sodium Chloride 500 mL bag
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Succinylcholine 200 mg/10 mL Syringe
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Ropivacaine HCL
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
OXYtocin 30 units added to 0.9% Sodium Chloride 500 mL bag
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Midazolam HCL 100 mg
Reason Lack of Assurance of Sterility.