Class II · Moderate risk Terminated
children's allergy relief
Reason Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
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
children's allergy
Reason Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Class II · Moderate risk Terminated
Children's 24 Hour Allergy
Reason Failed Impurities/Degradation Specifications: unknown impurity higher than the specified limit was detected during routine stability testing.
Class II · Moderate risk Terminated
HydrOXYzine HYDROCHLORIDE SYRUP
Reason CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility; bags have the potential to leak
Class II · Moderate risk Terminated
0.9% Sodium Chloride for Injection
Reason Lack of Assurance of Sterility
Class III · Low risk Terminated
Bupropion Hydrochloride ER Tablets
Reason Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter…
Reason cGMP Deviation
Class III · Low risk Terminated
Pramipexole dihydrochloride extended release tablets
Reason Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Class II · Moderate risk Terminated
Synjardy
Reason Cross Contamination With Other Products:
Class I · High risk Terminated
Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection
Reason Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection USP 100 mL bags
Reason CGMP Deviations
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended Release Tablets 1000 mg
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended Release Tablets 1000 mg
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Metformin Hydrochloride Extended Release Tablets
Reason Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Class II · Moderate risk Terminated
Rexall
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Rexall
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Rexall
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Best Choice
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Best Choice
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Best Choice
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Best Choice
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Rite Aid Pharmacy
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
QC Quality Choice
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
Class II · Moderate risk Terminated
Premier Value
Reason CGMP Deviations: products manufactured under conditions that could impact its product quality.
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