Calcium Antacid Tablet, Chewable
FDA Recall NDC 48433-106
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 Calcium Antacid (NDC 48433-106). A significant event, classified as Class II, was initiated on Nov 11, 2024 by Safecor Health, Llc. The reported reason for this action was: "cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Nov 11, 2024
Nov 27, 2024
791 boxes
Recall Profile & Regulatory Data
Event ID
95659
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Safecor Health, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
USA nationwide.
Product Description
Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01
Batch or Lot Expiration Information
Lot# 24A0073, exp. date 06/28/2026
Affected Packages Involved in this Recall
48433-106-01Product
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.
