Recall record at a glance
| Official record | F-0543-2021 |
|---|---|
| Category | Food Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Twenty-First Century Healthcare, Inc. |
| Report date | May 26, 2021 |
| Recall initiation date | May 7, 2021 |
| Quantity | 22,560 bottles distributed; 2,425 identified with incorrect label |
| Location | Tempe, AZ, United States |
Official product description
21st Century Vitamin D3 125 mcg (5000 IU) tablet, 100 count, UPC 7-40985-27431-6, 21st Century HealthCare, Inc., 2119 Wilson St., Tempe, AZ 85282
Why the product was recalled
A small quantity of bottles of Vitamin D3 125 mcg ((5000 IU) 100 ct. were mislabeled as Vitamin D3 25 mcg (1000 IU). Secondary labeling on the bottles (back label) is correctly labeled as Vitamin D3 125 mcg (5000 IU).
Distribution information
AZ
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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