Class II · Moderate risk Terminated
Vancomycin 50mg/mL Solution
Reason Lack of Assurance of Sterility
Is Vancomycin recalled?
Yes — there is an active recall. 22 ongoing FDA recalls mention Vancomycin (147 total). Check the affected lots below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Vancomycin. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed.
Class II · Moderate risk Terminated
Vancomycin 25mg/mL Solution
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vancomycin Injection in NS
Reason Lack of Assurance of Sterility
Class II · Moderate risk Terminated
Vancomycin HCL
Reason Lack of Assurance of Sterility: Product sterility cannot be guaranteed.
Class II · Moderate risk Terminated
Vancomycin Ophthalmic PF 0.5 mL
Reason Lack of Assurance of Sterility; The firm is recalling all sterile preparations that are within expiry due to deficient practices which may have an impact on sterility assurance.
Class II · Moderate risk Terminated
Vancomycin 25 mg/mL Opthalmic Solution
Reason Lack of Assurance of Sterility: Process deficiencies were observed in the sterile ophthalmic and injectable products that could have compromised the sterility of the product.
Class II · Moderate risk Terminated
Vancomycin 25 mg/ml Ophthalmic Solution
Reason Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Class II · Moderate risk Terminated
Vancomycin 1000mg / NS 100mL
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
Vancomycin 750 mg/NS 100 ml accuflo
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
Vancomycin HCl/Heparin
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
Vancomycin HCl
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
Vancomycin
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
Vancomycin HCl / Heparin
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
VANCOMYCIN HCL 250mg / NS 6mL syringe
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
Vancomycin HCl in Dextrose
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
Vancomycin HCl in Dextrose
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
VANCOMYCIN 1.25gm / NS 250mL AccuFlo
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
Vancomycin HCl in Dextrose
Reason Lack of Assurance of Sterility: Sterility of product is not assured.
Class II · Moderate risk Terminated
Fortified Vancomycin 25 mg/1 mL Opth Drops
Reason Lack of Assurance of Sterility and Stability Data does not Support Expiry: recent inspection observations associated with certain quality control procedures that present a risk to sterility and quality assurance.
Class II · Moderate risk Terminated
Vancomycin Hydrochloride Capsules
Reason Subpotent Drug
Class II · Moderate risk Terminated
Vancomycin Hydrochloride Capsules
Reason Subpotent Drug
Class II · Moderate risk Terminated
Vancomycin various strengths in normal saline bags
Reason Lack of sterility assurance.
Class II · Moderate risk Terminated
Vancomycin HCl active pharmaceutical ingredient packaged in…
Reason Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class III · Low risk Terminated
Sterile powder Vancomycin Hydrochloride for Injection
Reason Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another product.
Class II · Moderate risk Terminated
Vancomycin Hydrochloride for Injection
Reason Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.
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