Class II · Moderate risk Terminated
NORepinephrine added to 0.9% sodium chloride
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
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
NORepinephrine added to 0.9% sodium chloride
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
NORepinephrine added to dextrose 5%
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
EPINEPHrine added to 0.9% sodium chloride
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
NORepinephrine added to 0.9% sodium chloride
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
EPINEPHrine added to dextrose 5%
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
EPINEPHrine added to dextrose 5%
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
norepinephrine 4 mg added to dextrose 5% 250 mL*
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Terminated
EPINEPHrine added to dextrose 5%
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Class II · Moderate risk Ongoing
Pilocarpine Hydrochloride Ophthalmic Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Pilocarpine Hydrochloride Ophthalmic Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Pilocarpine Hydrochloride Ophthalmic Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Oxcarbazepine Oral Suspension
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class II · Moderate risk Ongoing
Atropine Sulfate Ophthalmic Solution
Reason CGMP Deviations: Firm went out of business and could no longer continue stability studies.
Class III · Low risk Terminated
Norepinephrine Bitartrate Injection
Reason Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity during routine product monitoring.
Class III · Low risk Terminated
Bevacizumab 2.5 mg/0.1 mL
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.
Class III · Low risk Ongoing
Epinephrine Professional EMS
Reason Labeling; Incorrect NDC number on outer carton of product.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Maximum Zone2 Topical Analgesic
Reason cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Class II · Moderate risk Terminated
New & Improved Blue Gel Anesthetic
Reason cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Class II · Moderate risk Terminated
Levothyroxine Sodium Tablets
Reason Sub-Potent Drug: Out of specification for assay at the 24 month interval.
Class III · Low risk Ongoing
Atropine Sulfate Ophthalmic Solution
Reason Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Class II · Moderate risk Terminated
S2 Racepinephrine Inhalation Solution
Reason Short Fill
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