Class II · Moderate risk Terminated
Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag
Reason Lack of sterility assurance.
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
Phenylephrine 40 mg in 0.9% Sodium Chloride 250 mL bag
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Lipoplex
Reason Lack of assurance of sterility for injectables and solutions intended to be sterile.
Class II · Moderate risk Terminated
Gentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation
Reason Lack of sterility assurance.
Class III · Low risk Terminated
Thallous Chloride TI 201 Injection
Reason Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
Class II · Moderate risk Terminated
Gavilyte-N
Reason Labeling Not Elsewhere Classified; orange and cherry flavor packets incorrect list "natural lemon flavor" as an ingredient
Class II · Moderate risk Terminated
Phenylephrine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Morphine Sulfate 30 mg/30 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Heparin 5
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Heparin 10 Units/10 mL 10 Units in 0.45% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Phenylephrine HCl
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Midazolam Benzodiazepine 50 mg/50 mL
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 2500 mcg/250 mL Injectable Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
fentaNYL 1000 mcg/100 mL Injectable Solution Fentanyl 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
HYDROmorphone HCl 1 mg in 0.9% Sodium Chloride
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Red Eye
Reason Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
Class II · Moderate risk Terminated
Little Remedies New Baby Essentials Kit. Each kit contains 1 each…
Reason Incorrect/undeclared excipients: Kit carton bear incorrect labeling for two of the five items contained within the kit.
Class III · Low risk Terminated
Mirapex
Reason Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Class III · Low risk Terminated
Oxybutynin Chloride Extended-Release Tablets USP 10 mg
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specifications; 9-monthstability timepoint
Class II · Moderate risk Terminated
Tamsulosin Hydrochloride Capsules
Reason Failed Dissolution Specifications: High Out-of-Specification dissolution results were observed during stability testing.
Class II · Moderate risk Terminated
SODIUM CHLORIDE PRES-FREE 5% OPHTH STERILE* SOLUTION. 20ml eye drops
Reason Lack of Processing Controls: Insanitary conditions observed during compounding of sterile drugs during recent FDA Inspection.
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