Class II · Moderate risk Terminated
Vancomycin 1.25g added to 250 mL of 0.9% Sodium Chloride IV bag
Reason Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
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
Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag
Reason Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Class III · Low risk Terminated
Methylphenidate Hydrochloride Extended-release Tablets
Reason Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
Class II · Moderate risk Terminated
Fluconazole Injection
Reason Labeling: Label mix-up - A complaint was received of one bag of Fluconazole Injection, Iso-Osmotic Sodium Chloride Diluent, USP, 2mg/mL, 50 mL found within the package of 100 mL bags.
Class II · Moderate risk Terminated
Labetalol Hydrochloride Injection
Reason Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
Class II · Moderate risk Terminated
0.9% Sodium Chloride Irrigation USP
Reason Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
Class II · Moderate risk Terminated
Vancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag
Reason Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Class II · Moderate risk Terminated
Vancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag
Reason Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
Class II · Moderate risk Terminated
Levocetirizine Dihydrochloride for prescription compounding
Reason CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
Class I · High risk Terminated
Hydromorphone
Reason Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class I · High risk Terminated
Hydromorphone
Reason Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
Class II · Moderate risk Terminated
0.2% Ropivacaine HCI
Reason Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Class II · Moderate risk Terminated
15 units Oxytocin added to 0.9% Sodium Chloride Injection
Reason Lack of assurance of sterility: Three lots were released where there was a failure to follow proper testing and investigation procedures. Product may be out of specification (OOS) for endotoxin.
Class III · Low risk Terminated
Metformin Hydrochloride Tablets
Reason Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg
Class II · Moderate risk Terminated
Velcade
Reason Defective Container: Confirmed reports of loose vial crimps.
Class III · Low risk Terminated
Oxycodone Hydrochloride Tablets
Reason Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol
Class II · Moderate risk Terminated
DOXOrubicin Hydrochloride Liposome Injection
Reason Lack Of Assurance Of Sterility
Class I · High risk Terminated
MAGnesium 2 gm in NS 100 mL Magnesium SULfate
Reason Subpotent
Class II · Moderate risk Terminated
Nicardipine HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Meperidine HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Labetalol HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Lidocaine HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Ropivacaine HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Methadone HCl in 0.9% Sodium Chloride in all strengths
Reason Lack of sterility assurance.
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