US Drug Recall Register

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: Firm did not adequately investigate customer complaints.

Wockhardt Usa Inc. D-1256-2015
Class II · Moderate risk Terminated

Amlodipine Besylate Tablets

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

Wockhardt Usa Inc. D-1255-2015
Class II · Moderate risk Terminated

Amlodipine Besylate Tablets

Reason CGMP Deviations: Firm did not adequately investigate customer complaints.

Wockhardt Usa Inc. D-1243-2015
Class II · Moderate risk Terminated

Nifedipine Extended-Release Tablets

Reason Failed Dissolution Specifications: High out of specification dissolution result at 1 hour time point.

Valeant Pharmaceuticals North America LLC D-1116-2015
Class I · High risk Terminated

EPINEPHrine HCl 4 mg added to 250 mL 0.9% Sodium Chloride Injection USP

Reason Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.

Pharmedium Services, LLC NDC 61553-119-61 D-1358-2015
Class I · High risk Terminated

EPINEPHrine HCl 16 mg added to 250 mL 0.9% Sodium Chloride Injection USP

Reason Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.

Pharmedium Services, LLC NDC 61553-618-61 D-1356-2015
Class I · High risk Terminated

EPINEPHrine HCl 1 mg added to 250 mL 0.9% Sodium Chloride Injection USP

Reason Presence of Particulate Matter: The firm produced products using 0.9% Sodium Chloride Injection, USP or 5% Dextrose Injection, USP which were subsequently recalled by the manufacturer due to the presence of particulate matter.

Pharmedium Services, LLC NDC 61553-244-61 D-1354-2015
Class III · Low risk Terminated

Olanzapine

Reason Subpotent drug

Apotex Inc. D-1081-2015
Class III · Low risk Terminated

Olanzapine

Reason Subpotent drug

Apotex Inc. NDC 60505-3276-03 D-1080-2015
Class III · Low risk Terminated

Olanzapine

Reason Subpotent drug

Apotex Inc. NDC 60505-3275-03 D-1079-2015
Class II · Moderate risk Terminated

Amlodipine Besylate Tablets USP

Reason Failed tablet specifications: One lot was found to contain oversized tablets.

Qualitest Pharmaceuticals NDC 0603-2110-32 D-0397-2015
Class II · Moderate risk Terminated

Phen 15 mg - Topri 92 mg SR Cap

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D1051-2015
Class II · Moderate risk Terminated

Hydrocortisone 1.6 mg/0.5 mL Susp

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1062-2015
Class II · Moderate risk Terminated

Nystatin 50

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1061-2015
Class II · Moderate risk Terminated

Coconut Oil Suppository

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1060-2015
Class II · Moderate risk Terminated

Cyclandelate 200 mg Caps

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1059-2015
Class II · Moderate risk Terminated

Triest 5 mg - Progest 150 mg Capsule

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1058-2015
Class II · Moderate risk Terminated

Colchicine 0.6 mg Caps

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1057-2015
Class II · Moderate risk Terminated

Lansoprazole 3 mg/mL Susp

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1056-2015
Class II · Moderate risk Terminated

Thymol 2% Solution

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1055-2015
Class II · Moderate risk Terminated

Methenamine/Phenyl Salicylate Capsule

Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.

Health Innovations Pharmacy, Inc D-1054-2015