Bisacodyl Suppository
FDA Recall NDC 57896-443
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Bisacodyl (NDC 57896-443). A significant event, classified as Class II, was initiated on Jun 29, 2022 by Geri-care Pharmaceutical Corp. The reported reason for this action was: "CGMP Deviations: products were stored outside the drug label specifications."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
CGMP Deviations: products were stored outside the drug label specifications.
Jun 29, 2022
Aug 17, 2022
45 boxes
Recall Profile & Regulatory Data
Event ID
90553
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Mckesson Medical-Surgical Inc. Corporate Office
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA.
Termination Date
Feb 13, 2024
Product Description
Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01.
Batch or Lot Expiration Information
Lot# Part# 444-01-HST
Affected Packages Involved in this Recall
57896-443-66Product
57896-443-12Product
57896-443-55Product
57896-443-05Product
57896-443-01Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
