Recalls / Class II
Class IID-0059-2025
Product
Calcium Carbonate Chewable 500 mg, 1 tablet in blister card-foils, 100-count unit dose box, www.safecorhealth.com, NDC 48433-106-01
- Brand name
- Calcium Antacid
- Generic name
- Calcium Carbonate
- Active ingredient
- Calcium Carbonate
- Route
- Oral
- NDC
- 48433-106
- FDA application
- M331
- Affected lot / code info
- Lot# 24A0073, exp. date 06/28/2026
Why it was recalled
cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Recalling firm
- Firm
- Safecor Health, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 317 New Boston St, N/A, Woburn, Massachusetts 01801-6231
Distribution
- Quantity
- 791 boxes
- Distribution pattern
- USA nationwide.
Timeline
- Recall initiated
- 2024-11-11
- FDA classified
- 2024-11-19
- Posted by FDA
- 2024-11-27
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0059-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.