Class II · Moderate risk Terminated
0.5% Bupivacaine HCl and Epinephrine 1:200
Reason Lack of assurance of sterility; equipment failure led to potential breach in asceptic process.
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
Amlodipine Besylate Tablets
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
Amlodipine Besylate Tablets
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
Amlodipine Besylate Tablets
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
Amlodipine Besylate Tablets
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
Amlodipine Besylate and Benazepril HCl Capsules
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
Amlodipine Besylate and Benazepril HCl Capsules
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
Amlodipine Besylate and Benazepril HCl Capsules
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
Amlodipine Besylate and Benazepril HCl Capsules
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
Amlodipine Besylate and Benazepril HCl Capsules
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
Amlodipine Besylate Tablets
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
Amlodipine Besylate and Benazepril HCl Capsules
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
Amlodipine Besylate Tablets
Reason CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices.
Class II · Moderate risk Terminated
0.5% Bupivacaine HCl and Epinephrine 1:200
Reason Lack of Assurance of Sterility; potential for vial breakage
Class II · Moderate risk Terminated
Epinephrine 1:1
Reason Lack of Assurance of Sterility: The product lots are being recalled due to laboratory results (from a contract lab) indicating microbial contamination. The FDA was concerned test results obtained from the recalling firm's contract testing lab may not be reliable. Hence the sterility of the products cannot be assured.
Class II · Moderate risk Terminated
Lidocaine Hydrochloride 2% and Epinephrine 1:100
Reason Subpotent Drug; Two lots of Lidocaine 2% with Epinephrine 1:100,000 Injectable, distributed under the names: Octocaine 100, and 2% Xylocaine Dental, may be subpotent for the epinephrine component.
Class II · Moderate risk Terminated
Exforge
Reason Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Class II · Moderate risk Terminated
Exforge
Reason Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Class II · Moderate risk Terminated
Exforge HCT
Reason Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Class II · Moderate risk Terminated
Exforge HCT
Reason Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Class II · Moderate risk Terminated
Exforge HCT
Reason Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Class II · Moderate risk Terminated
Exforge
Reason Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Class II · Moderate risk Terminated
Exforge
Reason Chemical Contamination: Novartis Pharmaceuticals Corporation has recalled physician sample bottles of Diovan, Exforge, Exforge HCT,Lescol XL, Stalevo, Tekturna and Tekturna HCT Tablets due to contamination with Darocur 1173 a photocuring agent used in inks on shrink-wrap sleeves.
Class II · Moderate risk Terminated
Benztropine Mesylate Injection
Reason Presence of particulate matter: characterized as thin colorless flakes that are visually and chemically consistent with glass delamination.
Class II · Moderate risk Terminated
Olanzapine Tablets
Reason Defective Container; This action is being taken as a precautionary measure due to the product being re-packaged in the U.S. using a filler material that (removes or blocks) less moisture than what is approved in the application.
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