Accord Healthcare Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL) recall — FDA D-0402-2023
CGMP Deviations: recalling drug products following an FDA inspection.
Overview of recall records associated with Accord Healthcare, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 86, Class III: 2, Class I: 2.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
CGMP Deviations: recalling drug products following an FDA inspection.
Presence of Foreign Substance: Presence of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
Labeling; Label Mix-up; correctly labeled 2 mL vials were packaged into blister strips labeled for 1 mL vials
Product Mix-Up: customer complaint that a sealed bottle labeled as Hydrochlorothiazide Tablets USP 12.5 mg contained only Spironolactone Tablets USP 25 mg.
This page summarizes recall records in which the official source identifies Accord Healthcare, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.