CLASS II Drug recall · Reported 21 Jun 2017 · FDA Enforcement Report
Calcium Carbonate 600mg/Vitamin D recalled by Safecor Health
Safecor Health is recalling Calcium Carbonate 600mg/Vitamin D, Pk By Safecor Health Woburn, MA 01801, distributed in Massachusetts, New York. The recall was initiated on 7 Jul 2016 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0902-2017
- FDA event ID
- 74822
- Recalling firm
- Safecor Health, Woburn, MA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Jul 2016
- FDA classified
- 12 Jun 2017
- Reported
- 21 Jun 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Vitamins & OTC Supplements
Timeline
| 7 Jul 2016 | Recall initiated by company | |
| 12 Jun 2017 | Classified by FDA | +340 days |
| 21 Jun 2017 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Calcium Carbonate 600mg/Vitamin D3 400 International Units tablets, 60-count bottles, Pk By Safecor Health Woburn, MA 01801, NDC 00904323392.
Where it was distributed
MA and NY
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Lot # A18705, Exp. 09/30/2017
Where was it sold?
MA and NY
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 74822More recalls from Safecor Health
All 30| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 2.5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 5 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 10 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
| Drug | CLASS II | Fluphenazine HCl Elixir, USP, 20 mg per, Delivers recalled | Safecor Health | Potency & Assay | Nationwide |
Other Calcium Carbonate recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Kirkland Signature, Ultra Strength Antacid recalled by Guardian Drug CoKirkland Ultra Stregth Antacid 171ab | Guardian Drug | Particulate Matter | Nationwide |
| Drug | CLASS II | Good Neighbor Pharmacy, extra strength Antacid Calcium recalledGood Neighbor Pharmacy Antacid | Guardian Drug | Particulate Matter | Nationwide |
| Drug | CLASS II | H.E.B Extra Strength Calcium Carbonate Antacid Tablets recalledHeb Extra Stregth Antacid | Guardian Drug | Particulate Matter | Nationwide |
| Drug | CLASS II | Family Wellness, Ultra Strengt, Antacid Tablets recalledFamily Wellness Ultra Strength Assorted Fruit Antacid | Guardian Drug | Particulate Matter | Nationwide |
| Drug | CLASS II | TopCare health, Extra Strength, Antacid Tablets recalledTopcare Extra Strength Antacid | Guardian Drug | Particulate Matter | Nationwide |