Recalls / Class II
Class IID-0524-2022
Product
4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-107-00
- Affected lot / code info
- Product Code: C107L Bulk Lots: 18G085, 19B061, 19F066, 19J068 Product Code: C107LB Bulk Lots: 18J051, 18M079, 18M080, 19B017, 19B018, 19C001, 19C081, 19D056, 19D057 Product C107LA: Bulk lots: 19F067
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
- Quantity
- 19,103,287 tablets
- Distribution pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product.
Timeline
- Recall initiated
- 2022-01-26
- FDA classified
- 2022-02-09
- Posted by FDA
- 2022-02-16
- Terminated
- 2025-01-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0524-2022. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.