Why it was recalled
CGMP Deviations
Product description
3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00
Lot numbers, UPCs & expiration codes
Product Code C106L; Bulk lots: 18J080, 18L029, 19A103, 19B063, 19D019, 19F065, Product Code C106LA; Bulk lots: 18K045, 18K046, 18L008, 18L105, 19A068, 19A094, 19A106, 19B009, 19C031, 19C032, 19C033, 19G085, 19H070, 19D018, 19H071, 19H082, 19J027
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-0523-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 26, 2022
- FDA report date
- Feb 16, 2022
- Quantity
- 33,758,436 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ULTRAtab Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0523-2022, 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 C106L; Bulk lots: 18J080, 18L029, 19A103, 19B063, 19D019, 19F065, Product Code C106LA; Bulk lots: 18K045, 18K046, 18L008, 18L105, 19A068, 19A094, 19A106, 19B009, 19C031, 19C032, 19C033, 19G085, 19H070, 19D018, 19H071, 19H082, 19J027
- Postal code
- 12528-1506
- Report date
- Feb 16, 2022
- Product type
- Drugs
- Recall number
- D-0523-2022
- Classification
- Class II
- Recalling firm
- ULTRAtab Laboratories, Inc.
- Product quantity
- 33,758,436 tablets
- Termination date
- Jan 7, 2025
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-106-00
- 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