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.
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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 I · High risk Terminated
diphenoxylate hydrochloride and atropine sulfate tablets
Reason SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class III · Low risk Terminated
Lumigan
Reason Failed Impurities/Degradation Specifications.
Class III · Low risk Terminated
Combigan
Reason Failed Impurities/Degradation Specifications.
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 III · Low risk Terminated
Methylphenidate Hydrochloride Tablets USP
Reason Failed Dissolution Specifications: Low out of specification results for dissolution.
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 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 II · Moderate risk Terminated
Levetiracetam Oral Solution
Reason Presence of foreign substance (screw)
Class III · Low risk Terminated
Clolar
Reason Labeling: Incorrect or Missing Package Insert.
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.