Class III · Low risk Terminated
Cequa
Reason Subpotent and Presence of Particulates .
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Class II · Moderate risk Completed
BusPIRone Hydrochloride Tablets
Reason Presence of Foreign Tablets/Capsules
Class II · Moderate risk Terminated
Micardis Tablets
Reason Subpotent Drug
Class III · Low risk Terminated
Atorvastatin Calcium Tablets
Reason Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Class II · Moderate risk Terminated
Metformin HCl Extended-Release Tablets
Reason Presence of foreign substance: identified as activated carbon.
Class I · High risk Terminated
1% Lidocaine HCl Injection
Reason Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Class I · High risk Terminated
0.5% Bupivacaine Hydrochloride Injection
Reason Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, USP may contain 1% Lidocaine HCl Injection, USP and some vials labeled to contain 1% Lidocaine HCl Injection, USP may contain 0.5% Bupivacaine Hydrochloride Injection, USP
Class III · Low risk Terminated
Thiamine HCl Injection
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 contain vials labeled with the incorrect lot number 200901.
Class II · Moderate risk Terminated
Sterile Water for Inj.
Reason Presence of Particulate Matter: particulate matter identified as an insect in one vial.
Class I · High risk Terminated
NP Thyroid 120 Thyroid Tablets
Reason Subpotent Drug
Class I · High risk Terminated
NP Thyroid 90 Thyroid Tablets
Reason Subpotent Drug
Class I · High risk Terminated
NP Thyroid 60 Thyroid Tablets
Reason Subpotent Drug
Class I · High risk Terminated
NP Thyroid 30 Thyroid Tablets
Reason Subpotent Drug
Class I · High risk Terminated
NP Thyroid 15 Thyroid Tablets
Reason Subpotent Drug
Class III · Low risk Terminated
Olmesartan Medoxomil Tablets
Reason Presence of Foreign Tablet/Capsule
Class II · Moderate risk Terminated
Cefixime for Oral Suspension USP 100 mg/5mL
Reason Subpotent Drug
Class III · Low risk Terminated
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk Terminated
DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk Terminated
DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk Terminated
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk Terminated
DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk Terminated
DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Class III · Low risk Terminated
DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Class II · Moderate risk Terminated
Sodium Chloride 0.9%
Reason Temperature Abuse: Product exposed to temperature outside specified limits.
Class II · Moderate risk Ongoing
Preferred Pharmaceuticals Inc.
Reason CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily Intake Limit (ADI) of 96ng/day.