Class II · Moderate risk Terminated
Asthmanefrin Racepinephrine Inhalation Solution Bronchodilator
Reason Discoloration
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
Epinephrine
Reason Subpotent drug.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium Tablets
Reason Subpotent Drug: Subpotent atorvastatin.
Class III · Low risk Terminated
Nisoldipine Extended Release Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Papaverine/Phentolamine/Atropine/Prostaglandin
Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk Terminated
Papaverine/Phentolamine/Atropine/Prostaglandin
Reason Lack of Assurance of Sterility; all sterile human compounded drugs within expiry
Class II · Moderate risk Terminated
atropine Sulfate Injection
Reason Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class II · Moderate risk Terminated
atropine Sulfate Injection
Reason Stability Data Does Not Support Expiry: potential loss of potency in drugs packaged and stored in syringes.
Class III · Low risk Terminated
Felodipine Extended-Release Tablets
Reason Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk Terminated
Felodipine Extended-Release Tablets
Reason Chemical Contamination; benzophenone leached from the product label varnish
Class III · Low risk Terminated
Felodipine Extended-Release Tablets
Reason Chemical Contamination; benzophenone leached from the product label varnish
Class II · Moderate risk Terminated
Phenobarbital/Hyoscyamine/ Atropine/Scopolamine…
Reason Labeling: Label Error on Declared Strength: Label incorrectly identifies product dose as 5ml instead of 10 ml.
Class II · Moderate risk Terminated
Papaverine/Phentolamine/Atropine/PGE-1 Injectable
Reason Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk Terminated
Papaverine/Phentolamine/Atropine/PGE-1 Injectable
Reason Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk Terminated
Lidocaine 2% with Epinephrine 1:100
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Terminated
Amlodipine besylate tablets
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Amlodipine besylate tablets
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class II · Moderate risk Terminated
Amlodipine besylate tablets
Reason CGMP Deviations: Firm did not adequately investigate customer complaints.
Class III · Low risk Terminated
Amlodipine besylate and Atorvastatin calcium tablets
Reason Subpotent drug
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