What happened
Original notice title
A&Z Pharmaceutical, Inc. MARCS-CMS 645101, June 01, 2023
From the archived source record
Research suggests calcium can help control high blood pressure, as it has been shown in several clinical trials that indicate increased calcium intake is linked to lower blood pressure and lower risk of hypertension. They also have a chance of getting a rare disease called rickets, which causes bone pain and soft, weak bones that can lead to bone deformities…Follow us D-Cal for facts and tips about healthy lifestyles to stay strong!...#dcal#dcalkids” Post dated June 25, 2021: “What happens if a child doesn't get enough calcium?...Kids who don't get enough calcium will have increased risk of bone fractures, not able to reach potential height, and osteoporosis later in life. Follow us D-Cal for facts and tips about healthy lifestyles to stay strong!#dcal #dcalkids” Post dated January 4, 2021: “Did you know vitamin D can help cut the risk of Covid-19? Remember to maintain a normal vitamin D intake level!...#covid19…#dcal…#dcalkids…”HOW VITAMIN D CUTSTHE RISK OF COVID-19…Covid-19 death rate by sunshine vitamin level…4.1% NORMAL***87.8%INSUFFICIENT…98.9% DEFICIENT...” Your product is not generally recognized as safe and effective for the above referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. 321(p)]. A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, Chewable Calcium 600MG with Vitamin D for Kids in Orange Flavor fails to bear adequate directions for its intended use and, therefore, the product is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of this misbranded drug violates section 301(a) of the Act [21 U.S.C. 331(a)]. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- FDA closeout listed
- Source checked
- Jul 16, 2026
- Record revision
- b4f41d0ac873
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →