VANCOMYCIN HYDROCHLORIDE

Generic: VANCOMYCIN HYDROCHLORIDE

Plano Pharmaceuticals Inc.Manufacturer

INTRAVENOUSRoute

VANCOMYCIN HYDROCHLORIDEActive Substance

2012-08-10Original Approval

VANCOMYCIN HYDROCHLORIDE is FDA application ANDA201048, sponsored by PLANO PHARMS. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2019-11-25

Vancomycin Hydrochloride for Injection, USP, 1 g* per vial, packaged in 10-count vials per carton, Rx only, Mft. in Indi

Discoloration: Product complaints of discoloration after reconstitution of vials.

Class I2017-08-30

Vancomycin Hydrochloride for Injection, USP. 750 mg. Sterile Powder. Rx Only. Hospira, Inc., Lake Forest, IL 60045 USA.

Presence of Particulate Matter: glass particulate found in vial

Class I2022-12-22

Vancomycin Hydrochloride for Injection, USP, 1.5 g/vial, Sterile powder, Single-dose Fliptop Vial, 10 vials per carton,

Presence of Particulate Matter: Glass particulate matter detected in injectable.

Class III2014-11-07

Sterile powder Vancomycin Hydrochloride for Injection, USP, Equivalent to 1 g in 25 ml fliptop vial, 10-count tray, Rx o

Correct Labeled Product Mispack: Product tray containing vials was mislabeled to contain another pro

Class II2014-10-06

Vancomycin Hydrochloride for Injection, USP, 1 g Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx on

Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

Class II2026-08-06

Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, St

CGMP Deviations

Class I2024-03-21

Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as (a) 80 mL bottle, NDC 69238-2261-3; (b) 15

Superpotent Drug: Due to overfilling of drug powder

Class II2026-08-06

Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Non

CGMP Deviations

Class II2014-10-06

Vancomycin Hydrochloride for Injection, USP, 500 mg Sterile Powder per Fliptop Vial, packaged in 10 Units per carton, Rx

Temperature Abuse: Products experienced uncontrolled temperature excursions during transit.

VANCOMYCIN HYDROCHLORIDE

Recalls

Top Reported Reactions