Class II · Moderate risk Terminated
Alpha Lipoic Acid
Reason Lack of Assurance of Sterility
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Class I · High risk Terminated
Natpara
Reason Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk Terminated
Natpara
Reason Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk Terminated
Natpara
Reason Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class I · High risk Terminated
Natpara
Reason Defective Delivery System: potential risk of rubber stopper particles clogging the needle and leading to underdosing
Class III · Low risk Terminated
Zarontin
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class III · Low risk Terminated
ethosuximide capsules
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is incorrect. The label states an expiry date of 09/2021 when it should be 09/2020.
Class II · Moderate risk Terminated
Oxcarbazepine Oral Suspension
Reason Failed Impurities/Degradation Specificattion
Class II · Moderate risk Terminated
Nucala
Reason Temperature Abuse; Product stored and shipped outside of labeled storage requirements.
Class II · Moderate risk Terminated
Anagrelide Capsules
Reason Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities detected during routine stability testing.
Class II · Moderate risk Terminated
Bacteriostatic Water for Injection
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Gatifloxacin Ophthalmic Solution 0.5%
Reason Failed Impurities/Degradation Specifications:OOS for unknown impurity.
Class III · Low risk Terminated
Matzim LA
Reason GMP Deviation: lot not intended for commercial distribution.
Class I · High risk Terminated
Quinacrine Dihydrochloride
Reason Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified as Artemisinin.
Class II · Moderate risk Terminated
Pantoprazole Sodium Delayed Release Tablets
Reason CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Class II · Moderate risk Terminated
5% Acetyl-L-Cysteine Ophthalmic Solutions
Reason Lack of Processing Controls:
Class II · Moderate risk Terminated
10% Acetyl-L-Cysteine Ophthalmic Solutions
Reason Lack of Processing Controls:
Class II · Moderate risk Terminated
20% Acetyl-L-Cysteine Ophthalmic Solutions
Reason Lack of Processing Controls:
Class II · Moderate risk Terminated
Hydromorphone HCL and Clonidine HCL and Fentanyl Citrate in all strengths
Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk Terminated
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine…
Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk Terminated
Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine…
Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk Terminated
Fentanyl Citrate and Clonidine HCL and Morphine Sulfate and…
Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk Terminated
Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL in all strengths
Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk Terminated
Fentanyl Citrate and Bupivacaine HCL and Clonidine HCL and…
Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.
Class II · Moderate risk Terminated
Baclofen and Clonidine HCL and Morphine Sulfate in all strengths
Reason Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identified as Talaromyces rotundus, a fungi.