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 III · Low risk Terminated

Quetiapine Fumarate Extended-Release Tablets

Reason Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

The Harvard Drug Group D-1001-2020
Class III · Low risk Terminated

Quetiapine Fumarate Extended-Release Tablets

Reason Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

The Harvard Drug Group D-1000-2020
Class III · Low risk Terminated

Quetiapine Fumarate Extended-Release Tablets

Reason Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.

The Harvard Drug Group D-0999-2020
Class II · Moderate risk Terminated

Caduet

Reason Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.

Pfizer Inc. NDC 0069-2160-30 D-0842-2020
Class II · Moderate risk Terminated

Caduet

Reason Defective Container: products potentially could have been packaged in defective bottles, with a notched rim, that could cause inadequate foil sealing resulting in lack of moisture protection.

Pfizer Inc. NDC 0069-2180-30 D-0841-2020
Class I · High risk Terminated

Mirtazapine Tablets

Reason Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.

AuroMedics Pharma LLC NDC 13107-001-05 D-0637-2020
Class I · High risk Terminated

Mirtazapine Tablets

Reason Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.

AuroMedics Pharma LLC NDC 13107-031-05 D-0636-2020
Class II · Moderate risk Terminated

Quadmix # 19

Reason Lack of Assurance of Sterility

KRS Global Biotechnology, Inc D-0092-2020
Class II · Moderate risk Terminated

Quadmix #13A

Reason Lack of Assurance of Sterility

KRS Global Biotechnology, Inc D-0091-2020
Class II · Moderate risk Terminated

Oxcarbazepine Oral Suspension

Reason Failed Impurities/Degradation Specificattion

West-Ward Columbus Inc D-1863-2019
Class II · Moderate risk Terminated

S-Atropine 0.5% Opth Soln

Reason Lack of Assurance of Sterility

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0203-2020
Class II · Moderate risk Terminated

S-Atropine 0.02% Opthalmic Solution

Reason Lack of Assurance of Sterility

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0202-2020
Class II · Moderate risk Terminated

S-Atropine 0.01% Ophthalmic Solution

Reason Lack of Assurance of Sterility

First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy D-0201-2020
Class II · Moderate risk Terminated

Carbamazepine

Reason Failed Dissolution Specifications

American Health Packaging D-1821-2019