Class II · Moderate risk Terminated
Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only
Reason Subpotent drug.
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
Hydroxyzine Hydrochloride Oral Solution
Reason Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Class II · Moderate risk Terminated
Sodium Chloride Injection
Reason Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2ml vial.
Class I · High risk Terminated
TraZODONE Hydrochloride Tablets USP 100 mg
Reason Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during bottling at a 3rd party facility.
Class III · Low risk Terminated
Scandonest 3% Plain
Reason Labeling: Label mix-up
Class II · Moderate risk Terminated
Irinotecan Hydrochloride Injection
Reason CGMP Deviations: based on a Warning Letter received by the manufacturer of the recalled product for inadequate out-of specification investigations, complaint and the investigation conclusions.
Class I · High risk Terminated
Dexmedetomidine HCl in 0.9% Sodium Chloride Injection
Reason Cross Contamination with other products: trace amounts of lidocaine
Class III · Low risk Terminated
DOXOrubicin Hydrochloride Injection
Reason Cross Contamination with Other Products: trace amounts of octreotide found during testing
Class III · Low risk Terminated
Levocetirizine Dihydrochloride Tablets
Reason Failed Impurities/Degradation Specifications: One lot of Levocetirizine dihydrochloride tablets 5 mg 30 count failed stability testing.
Class II · Moderate risk Terminated
clomiPRAMINE Hydrochloride Capsules USP
Reason Failed Tablet/Capsule Specification
Class II · Moderate risk Terminated
Sodium Chloride Injection
Reason Failed pH Specifications: Out of Specification pH Test Results were found in Sodium Chloride Injection USP 0.9% 2 mL vial.
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended Release 750 mg
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk Ongoing
Metformin Hydrochloride Extended-Release Tablets USP 750 mg
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level (per manufacturer)
Class II · Moderate risk Terminated
Bupivacaine Hydrochloride in 8.25% Dextrose Injection
Reason Presence of particulate matter in solution - black and transparent particles
Class II · Moderate risk Terminated
Catapres
Reason An extraneous peak was observed for dissolution testing.
Class II · Moderate risk Terminated
Catapres
Reason An extraneous peak was observed for dissolution testing.
Class II · Moderate risk Terminated
Catapres
Reason An extraneous peak was observed for dissolution testing.
Class II · Moderate risk Terminated
Time-Cap Labs
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class II · Moderate risk Terminated
Time-Cap Labs
Reason CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level
Class III · Low risk Terminated
Metformin Hydrochloride Tablets USP
Reason Presence of Foreign Tablets/Capsules: Metformin 1000mg with different imprint was found in bottles.
Class II · Moderate risk Terminated
Riomet ER
Reason CGMP Deviations: Detection of N-nitrosodimethylamine (NDMA) impurity in finished drug product.
Class II · Moderate risk Terminated
Strides Pharma Inc.Potassium Chloride Extended-Release Tablets
Reason Failed Dissolution Specifications
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