Class II · Moderate risk Ongoing
Amlodipine and Valsartan Tablets
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Is Pine recalled?
Yes — there is an active recall. 82 ongoing FDA recalls mention Pine (685 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Class II · Moderate risk Terminated
PRO/PA/PH/AT 18mcg/1.8mg/
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Atropine 0.01% Opth Solution
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Class II · Moderate risk Terminated
Potassium Chloride For Injection Concentrate syringe 40 mEq/20 mL
Reason CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 16 mg
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 8 mg
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 4 mg
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Class II · Moderate risk Terminated
NORepiNEPHrine4mg
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
NORepiNEPHrine4mg
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
NORepiNEPHrine Bitartrate
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
NORepiNEPHrine 16
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
NORepiNEPHrine 8 mg
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
EPINEPHrine
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
EPINEPHrine
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Class II · Moderate risk Terminated
Loxapine Capsules
Reason GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Class II · Moderate risk Terminated
Loxapine Capsules
Reason GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross contamination
Class II · Moderate risk Terminated
Loxapine Capsules
Reason CGMP Deviations
Class II · Moderate risk Terminated
Loxapine Capsules
Reason CGMP Deviations
Class II · Moderate risk Terminated
Amlodipine and Benazapril HCL Capsules
Reason cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Class II · Moderate risk Terminated
Amlodipine and Benazapril HCL Capsules
Reason cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Class II · Moderate risk Terminated
Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml
Reason Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns may not be sufficient to support the aseptic production of certain injectable drug products.
Class III · Low risk Terminated
Brilliant Blue G for Intraocular Injection 0.5mL vial 0.25 mg/mL…
Reason Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for incorrect product.
Class III · Low risk Terminated
Lupin Hydrocodone Bitartrate and Homatropine Methylbromide Tablets
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Atropine Sulfate Ophthalmic 1% Solution
Reason Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Class II · Moderate risk Terminated
Nifedipine USP for prescription compounding
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
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