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

Epinephrine

Reason Lack of Assurance of Sterility

Pharmakon Pharmaceuticals, Inc. NDC 45183-0135-70 D-1266-2016
Class II · Moderate risk Terminated

All mirtazapine Products

Reason Lack of Processing Controls

Reliable Rexall-A Compounding Pharmacy D-1106-2016
Class II · Moderate risk Terminated

All nifedipine Products

Reason Lack of Processing Controls

Reliable Rexall-A Compounding Pharmacy D-1100-2016
Class II · Moderate risk Terminated

Formula 2

Reason Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

Meditech Laboratories, Inc D-0808-2016
Class II · Moderate risk Terminated

Formula 3

Reason Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

Meditech Laboratories, Inc D-0806-2016
Class II · Moderate risk Terminated

Formula 1

Reason Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.

Meditech Laboratories, Inc D-0805-2016
Class II · Moderate risk Terminated

Formula 9

Reason Lack of Assurance of Sterility: incomplete or missing data regarding production.

Meditech Laboratories, Inc D-0804-2016
Class II · Moderate risk Terminated

Formula 4

Reason Lack of Assurance of Sterility: incomplete or missing data regarding production.

Meditech Laboratories, Inc D-0803-2016
Class II · Moderate risk Terminated

Formula 2

Reason Superpotent Drug: one ingredient was found to be above assay specification.

Meditech Laboratories, Inc D-0802-2016
Class III · Low risk Terminated

Amlodipine Besylate Tablets USP

Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Lupin Limited NDC 68180-752-03 D-1493-2016
Class III · Low risk Terminated

Amlodipine Besylate Tablets USP

Reason CGMP Deviations: finished products manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

Lupin Limited NDC 68180-750-09 D-1492-2016
Class II · Moderate risk Terminated

Atropine 0.01% Ophth Solution

Reason Lack of Assurance of Sterility

Walter's Pharmacy NDC 99999-9019-09 D-0793-2016
Class III · Low risk Terminated

NORepinephrine Bitartrate

Reason Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration

Pharmedium Services, LLC NDC 61553-127-61 D-0778-2016
Class III · Low risk Terminated

NORepinephrine Bitartrate

Reason Subpotent Drug; confirmed results by FDA analysis after customer complaints of discoloration

Pharmedium Services, LLC NDC 61553-134-61 D-0777-2016
Class I · High risk Terminated

Auvi-Q

Reason Defective Delivery System; potential to have inaccurate dosage delivery

Sanofi-Aventis U.S. LLC NDC 0024-5831-02 D-0873-2016
Class I · High risk Terminated

Auvi-Q

Reason Defective Delivery System; potential to have inaccurate dosage delivery

Sanofi-Aventis U.S. LLC NDC 0025-5833-02 D-0872-2016
Class III · Low risk Terminated

Donnatal

Reason Labeling: Not elsewhere classified - Product label incorrectly lists Scopolamine Hydrocodone as an active ingredient on the side panel instead of Scopolamine Hydrobromide.

Rx PAK NDC 59212-425-10 D-0053-2016
Class II · Moderate risk Terminated

Pilocarpine

Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.

US Compounding Inc D-0278-2016