Class II · Moderate risk Terminated
Potassium Chloride in 5% Dextrose in all strengths
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 HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Succinylcholine Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ketamine HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Potassium Chloride in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Fentanyl Citrate in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Morphine Sulfate in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Midazolam HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Bupivacaine HCl in 0.9% Sodium Chloride in all doses
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
HYDROmorphone HCl in Sodium Chloride 0.9% in all doses
Reason Lack of sterility assurance.
Class III · Low risk Terminated
Methylphenidate Hydrochloride Extended-release Tablets
Reason Subpotent Drug
Class III · Low risk Terminated
Methylphenidate Hydrochloride Extended-release Tablets
Reason Subpotent Drug
Class II · Moderate risk Terminated
Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP
Reason Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing.
Class II · Moderate risk Terminated
Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe
Reason Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date.
Class II · Moderate risk Terminated
Oxytocin 30 Units in 0.9% Sodium Chloride Solution
Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of at least one ingredient used to make final product.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Injection
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
ePHEDrine Sulfate In 0.9% Sodium Chloride
Reason Subpotent Drug
Class III · Low risk Terminated
Meclizine hydrochloride tablets USP
Reason Marketed without an approved NDA/ANDA: Bottles were released prior to final approval.
Class I · High risk Terminated
diphenoxylate hydrochloride and atropine sulfate tablets
Reason SUPERPOTENT: Weight variations resulting in tablets that are sub and super potent
Class II · Moderate risk Terminated
Calcium GLUCOnate 2 g added to 0.9% Sodium Chloride 50 mL Bag
Reason Lack Of Assurance Of Sterility.
Class II · Moderate risk Terminated
PHENYLephrine HCl 100 mcg per mL In 0.9% Sodium Chloride 10 mL…
Reason Lack Of Assurance Of Sterility.
Class II · Moderate risk Terminated
morphine sulfate 1 mg per mL in 0.9% Sodium Chloride a) Total…
Reason Lack Of Assurance Of Sterility.
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