Class II · Moderate risk Terminated
Epi-Pen 2-Pak
Reason cGMP deviations: Temperature abuse
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
Formula F2
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
FA, Papaverine 20 mg/mL . Phentolamine 2 mg/mL . Alprostadil 20…
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Qm-4
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Qm-3
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
At-1
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
At-6
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
Formula F9
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class II · Moderate risk Terminated
QM-2 Papaverine 30 mg/mL. Phentolamine 3 mg/mL . Alprostadil 60…
Reason CGMP Deviations: prior to October 1, 2021, environmental and personnel monitoring Out of Action Limit (OOAL) excursions were not being properly investigated
Class I · High risk Terminated
Symjepi
Reason Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Class I · High risk Terminated
Symjepi
Reason Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Class II · Moderate risk Terminated
Epinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride
Reason Defective container
Class II · Moderate risk Terminated
Norepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride
Reason Defective container
Class II · Moderate risk Terminated
Norepinephrine Bitartrate Injection 16 mg per 250 mL added to…
Reason Defective container
Class II · Moderate risk Terminated
Norepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride
Reason Defective container
Class III · Low risk Terminated
Formula F9
Reason Sub Potent
Class II · Moderate risk Terminated
Olanzapine Tablets
Reason cGmp Deviations
Class II · Moderate risk Terminated
Amlodipine and Olmesartan Medoxomil Tablets
Reason cGMP deviations
Class III · Low risk Terminated
Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%
Reason Subpotent drug
Class II · Moderate risk Terminated
Norepinephrine Bitartrate Injection USP 4 mg/4 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
LET Topical Gel
Reason CGMP Deviations
Class II · Moderate risk Terminated
Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Lidocaine HCl/Epinephrine
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Carbamazepine Tablets
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Norepinephrine
Reason Lack of Assurance of Sterility
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