Class II · Moderate risk Terminated
Nicardipine HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
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
Nicardipine HCl in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Atropine Sulfate Injection in all strengths
Reason Lack of sterility assurance.
Class III · Low risk Terminated
Isradapine Capsules USP 2.5 mg
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Clozapine Tablets USP
Reason Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Class I · High risk Terminated
diphenoxylate hydrochloride and atropine sulfate tablets
Reason SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class II · Moderate risk Terminated
Norepinephrine Bitartrate16 mg added to 0.9% Sodium Chloride 250 mL bag
Reason Lack of Assurance of Sterility.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 8 mg added to 0.9% Sodium Chloride 250 mL in a bag
Reason Lack of Assurance of Sterility.
Class III · Low risk Terminated
Carbamazepine Oral Suspension USP
Reason Subpotent Drug: low out of specification results.
Class II · Moderate risk Terminated
Levophed
Reason Lack of sterility assurance: resulting from use of a damaged sterilizing filter for nitrogen used in the manufacturing process.
Class II · Moderate risk Terminated
Norepinephrine 8 mg in dextrose 5% 250 mL
Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product have been identified as actually containing microorganisms.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock
Reason Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk Terminated
NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL
Reason Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk Terminated
NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock
Reason Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk Terminated
EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL
Reason Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk Terminated
Carbamazepine Oral Suspension
Reason Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product carton lists incorrect volume and NDC.
Class II · Moderate risk Terminated
Clindamycin Injection USP
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Clindamycin Injection USP
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Clindamycin Injection USP
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Levophed norepinephrine bitartrate
Reason GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Class II · Moderate risk Terminated
Saphris 10 mg
Reason Labeling; Label Mixup; blister lidding foil and shell-pack labeled as 10 mg but package actually contains 5 mg tablets
Class III · Low risk Terminated
Amlodipine Besylate Tablet
Reason PRESENCE OF FOREIGN TABLETS/CAPSULES: A 2.5 mg Amlodipine Besylate tablet was found co-mingled with 10 mg Amlodipine Besylate tablets in a bottle labeled as Amlodipine Besylate 10 mg.
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