Class II · Moderate risk Terminated
Norepinephrine 16 mg per 250 mL (64 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units…
Reason Lack of Assurance of Sterility
Is Chloride recalled?
Yes — there is an active recall. 326 ongoing FDA recalls mention Chloride (1,994 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Chloride. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Class II · Moderate risk Terminated
Norepinephrine 8 mg per 250 mL (32 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Norepinephrine 4 mg per 250 mL (16 mcg per mL) in 0.9% Sodium Chloride, 250 mL Single Dose bag, packaged in 250 mL x 12 units per…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP, 1000 mL Excel Plus Container, Rx only, B. Braun Medical Inc. Bethlehem, PA 18018-3524 USA…
Reason Lack of assurance of sterility: bags have the potential to leak.
Class II · Moderate risk Ongoing
Tizanidine Hydrochloride Tablet 4mg, packaged in a) 20 count-bottles (NDC 68788-7781-2), b)30-count bottles (NDC: 68788-7781-3)…
Reason Failed Stability Specifications
Class II · Moderate risk Terminated
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries…
Reason Packaging defect: blister packaging inadequately sealed.
Class I · High risk Terminated
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited…
Reason Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and…
Class II · Moderate risk Terminated
Sodium Chloride 0.9% Injection, USP, 1000 mL bags, 12 bags per carton, Rx only, Fresenius Medical Care North America, Waltham, MA…
Reason Lack of assurance of sterility: The product was potentially exposed to below-recommended storage temperatures, which may cause leaks in the packaging.
Class III · Low risk Terminated
Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4…
Reason Product Mix up; Product was compounded in 250 mL 5% Dextrose instead of 250 mL 0.9% Sodium Chloride
Class II · Moderate risk Terminated
buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical…
Reason Failed Dissolution Specifications; during stability testing
Class II · Moderate risk Ongoing
VANComycin 1.5g added to 250 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
FentaNYL 500 mcg (2mcg/mL) and Ropivacaine HCL 250 mg (0.1%) added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 750mg added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 2.5 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 2g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only. Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.75 g added to 500 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1 g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.25g added to 250 mL of 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
Norepinephrine 8 mg added to 250 mL 0.9% Sodium Chloride Injection, Rx Only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Ongoing
VANComycin 1.5g added to 500 mL of 0.9% Sodium Chloride Injection, Rx only, Apollo Care, LLC, 3801 Mojave Ct., Suite 101…
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
vasopressin 50 units added to 0.9% sodium chloride 50 mL*, 1 unit/mL*, 50 mL in 100 mL Partial Additive Bag, Rx only, Central…
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
vasopressin 40 units added to 0.9% sodium chloride 100 mL*, 0.4 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy…
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
vasopressin 20 units added to 0.9% sodium chloride 100 mL*, 0.2 units/mL*, 100 mL per bag, Rx only, Central Admixture Pharmacy…
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
heparin added to 0.9% sodium chloride, 2,500 units/500 mL* (5 units/mL), 500 mL per bag, Rx only, Central Admixture Pharmacy…
Reason Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
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