Pharmacy Innovations THIAMINE/RIBOFLA/NIACINAMI/DEXPANTH/PYRIDOX/HYDROXYCOBAL recall — FDA D-0239-2023
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Browse U.S. drug recall enforcement reports from the FDA in a structured, searchable format. Review the recalled product, reason, firm, status, dates, distribution information and FDA classification when available.
10,685 detailed records are currently available in this category.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
CGMP Deviations: potential for trace amounts of product carryover.
Discoloration: Product complaints of the repackaged Epinephrine API being discolored which could result in less effective product
Presence of Particulate Matter: Glass particulate matter detected in injectable.
Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility.
CGMP Deviations: potential for trace amounts of product carryover.
Short Fill
Labeling: Illegible Label; the adhesive migrated onto a portion of the label, causing it to tear when peeled back
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary…
Labeling mixup: cartons labeled as Daptomycin 350 mg/vial were found to contain vials of Daptomycin 500 mg per vial
CGMP Deviations and Superpotent Drug: Levels of acetal and acetaldehyde above allowable limits. Additionally, lot 001 was superpotent.
CGMP Deviations:
Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product.
CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary…
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