FDA Food Recalls

Recalls / Class II

Class IIF-0723-2022

Product

Caffeine 125 mg with B6 and B12 vitamins (supplement), ULTRAtab Laboratories, Inc., Highland, NY

Type
Food
Affected lot / code info
Product Codes: M960L Bulk Lots: 19E021, 19E022
Quantity
1,904,760 tablets

Why it was recalled

cGMP Deviations

Recalling firm

Firm
ULTRAtab Laboratories, Inc.
Notification channel
Letter
Type
Voluntary: Firm initiated
Address
50 Toc Dr, N/A, Highland, New York 12528-1506

Distribution

Distribution pattern
Bulk product was distributed to 2 distributors (NY, FL) who may have repackaged the product and further distributed finished product.

Timeline

Recall initiated
2021-10-06
FDA classified
2022-02-09
Posted by FDA
2022-02-16
Terminated
2022-09-01
Status
Terminated

Source: openFDA Food Enforcement endpoint. Recall record F-0723-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings.