Why it was recalled
CGMP Deviations
Product description
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
Lot numbers, UPCs & expiration codes
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
Where it was sold
Bulk product was distributed to 3 distributors who may have distributed finished product.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0524-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 26, 2022
- FDA report date
- Feb 16, 2022
- Quantity
- 19,103,287 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ULTRAtab Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0524-2022, exactly as published.
Show all FDA fields
- City
- Highland
- State
- NY
- Status
- Terminated
- Country
- United States
- Event ID
- 89334
- Address
- 50 Toc Dr
- Code information
- 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
- Postal code
- 12528-1506
- Report date
- Feb 16, 2022
- Product type
- Drugs
- Recall number
- D-0524-2022
- Classification
- Class II
- Recalling firm
- ULTRAtab Laboratories, Inc.
- Product quantity
- 19,103,287 tablets
- Termination date
- Jan 7, 2025
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Bulk product was distributed to 3 distributors who may have distributed finished product.
- Recall initiation date
- Jan 26, 2022
- Initial firm notification
- Letter
- Center classification date
- Feb 9, 2022