Recalls / Class II
Class IIF-0721-2022
Product
Ephrine Plus Tablet (Caffeine 200 mg, Vitamin C 25 mg) Supplement, ULTRAtab Laboratories, Inc., Highland, NY
- Type
- Food
- Affected lot / code info
- Product Codes: M943 M943L Bulk Lots: 16K038, 18B075
- Quantity
- 4,250,842 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-0721-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings.