Class II · Moderate risk Terminated
NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh…
Reason Lack of Assurance of Sterility
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, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per mL), Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY 12903…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
QUAD-MIX PAPAV 30/PHENTOL 4/PGE-1 40/ATROPINE 0.4 INJ *C6* INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
QUAD-MIX PAPAV 30/PHENTOL 3/PGE-1 100/ATROPINE 0.2 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 30/ATROPINE 0.2 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 200/ATROPINE 0.02 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
QUAD-MIX PAPAV 30/PHENTOL 2/PGE-1 20/ATROPINE 0.2 INJ *C5* INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 20/ATROPINE 0.1 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
QUAD-MIX PAPAV 30/PHENTOL 1/PGE-1 10/ATROPINE 0.15 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
QUAD-MIX PAPAV 20/PHENTOL 2/PGE-1 25/ATROPINE 0.2 INJ INJECTABLE, Rx only, Talon Compounding Pharmacy, 2950 Thousand Oaks Drive…
Reason Lack of assurance of sterility
Class II · Moderate risk Terminated
Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd…
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, packaged in 10 vial cartons (NDC 0703-1153-03) Rx…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count…
Reason Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Class II · Moderate risk Terminated
Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis…
Reason cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Class II · Moderate risk Terminated
Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP), 1%, 300 mg/30 mL, (10 mg/mL), 30 mL…
Reason Low out of specification results for epinephrine assay.
Class III · Low risk Terminated
Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 mg, 30-count bottle, Rx only, Mfd. By:KVK-Tech…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
Reason Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor…
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