Class II · Moderate risk Terminated
Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging.
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, all doses, and all packaging.
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Atropine Sulfate Injection in all strengths, all doses, and all packaging.
Reason Lack of sterility assurance.
Class III · Low risk Terminated
Isradapine Capsules USP 2.5 mg, 100-count bottles, Rx only, Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647, NDC…
Reason Failed Impurities/Degradation Specifications
Class II · Moderate risk Terminated
Clozapine Tablets USP, 100 mg, 500 count bottles, Rx only, Manufactured in Israel by: TEVA PHARMACEUTICALS IND, LTD, Jerusalem…
Reason Failed Tablet/Capsule Specifications; potential presence of broken tablets.
Class I · High risk Terminated
diphenoxylate hydrochloride and atropine sulfate tablets, USP, 2.5 mg/0.025 mg, a) 100-count bottle (NDC 59762-1061-1), b)…
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, Rx Only, Banner Health Compounding Pharmacy 7300 W…
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, Rx Only, Banner Health Compounding Pharmacy 7300…
Reason Lack of Assurance of Sterility.
Class III · Low risk Terminated
Carbamazepine Oral Suspension USP, 100 mg/5 mL, 5 mL Unit Dose Cups (NDC 68094-301-59), packaged in 10-count cups per tray, 3…
Reason Subpotent Drug: low out of specification results.
Class II · Moderate risk Terminated
Levophed (norepinephrine bitartrate) injection, USP, 4 mg/4 mL (1mg/mL), 4mL Fill in 5 mL Single dose Fliptop Vial, Rx only…
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, 250mL IV Bag, Concentration: 0.032 mg/mL, This is a compounded injectable drug; Rx…
Reason Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufacturing process. No batches of distributed product…
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug…
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug…
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg per mL) Single-Dose Bag, Rx Only, Cantrell Drug…
Reason Lack of Sterility Assurance.
Class II · Moderate risk Terminated
NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little…
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, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205…
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, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205…
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, Rx only, SCA Pharmaceuticals 8821 Knoedl Ct Little Rock, AR 72205 --- NDC#…
Reason Lack of Assurance of Sterility; product has the potential to leak.
Class II · Moderate risk Terminated
Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only, Pkg: Precision Dose, Inc., S. Beloit, IL 61080…
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; 900 mg/6 mL (150 mg/mL). 6 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Clindamycin Injection USP; 600 mg/4 mL (150 mg/mL). 4 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Clindamycin Injection USP; 300 mg/2 mL (150 mg/mL). 2 mL Single-dose ADD-VANTAGE Vial, Rx Only, Manufactured for Alvogen, Inc…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx only, Hospira, Inc. Lake Forest, IL --- NDC…
Reason GMP Deviation; A foreign stopper was observed during packaging of a lot of product.
Class II · Moderate risk Terminated
Saphris 10 mg (asenapine) sublingual tablets, 6x10 count blister packs, Rx only, Black Cherry Flavor, Manufactured by: Catalent…
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, USP, 10 mg, 1000 count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013…
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…
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