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.
Reason CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Reason Lack of Assurance of Sterility: Practices at firm may call into question the sterility of products intended to be sterile.
Reason CGMP Deviations: Syringes were filled with 19mL of potassium chloride when the labels displayed a fill of 20mL.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: SCA is conducting a voluntary recall of certain lots of sterile admixtures due to a potential for leakage.
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Reason Lack of Assurance of Sterility: Potential leakage of bags.
Reason GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross…
Reason GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violations that would place Loxapine at risk for cross…
Reason CGMP Deviations
Reason CGMP Deviations
Reason cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was not followed according to procedure
Reason cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not followed according to procedure
Reason Lack of assurance of sterility: Upon review of recent 3rd party environmental certification documentation, it was determined that airflow patterns…
Reason Labeling: Label Mix-Up: Brilliant Blue G was labeled with an inaccurate auxiliary label which contained active/inactive ingredient information for…
Reason Failed Impurities/Degradation Specifications
Reason Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure…
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