Ben Venue Laboratories CYTARAbine for Injection USP, lyophiled in glass vials, 1 gram per recall — FDA D-1543-2014
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Overview of recall records associated with Ben Venue Laboratories Inc., including dates, categories and classifications where available.
Classification mix: Class II: 4, Class I: 2.
Lack of Assurance of Sterility: Crimp defects during visual inspection could affect container closure integrity.
Presence of Particulate Matter: During a review of retain samples, the firm found a glass particulate in one lot of Acetylcysteine Solution
Presence of Particulate Matter: visible crystalline particulates and the discovery of crystalline particulate in a retain sample.
Presence of Particulate Matter
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
Short Fill: These products are being recalled because there is potential that vials with low fill volume were released into distribution.
This page summarizes recall records in which the official source identifies Ben Venue Laboratories 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.