Why it was recalled
CGMP Deviations
Product description
HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00
Lot numbers, UPCs & expiration codes
Product Codes: L242SRC Bulk Lot: 18K086, 18L009, 18L050, 18L083, 18M025, 18M073, 18M098, 19A010, 19A084, 19A105, 19A107; Product Code: L242L Bulk Lot: 19H014; Product Code: L242PA Bulk Lot: 18F072, 18L119, 19A067, 19G043; Product Code: L242N Bulk Lot: 19H040
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-0538-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 26, 2022
- FDA report date
- Feb 16, 2022
- Quantity
- 50,585,623 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ULTRAtab Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0538-2022, 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 Codes: L242SRC Bulk Lot: 18K086, 18L009, 18L050, 18L083, 18M025, 18M073, 18M098, 19A010, 19A084, 19A105, 19A107; Product Code: L242L Bulk Lot: 19H014; Product Code: L242PA Bulk Lot: 18F072, 18L119, 19A067, 19G043; Product Code: L242N Bulk Lot: 19H040
- Postal code
- 12528-1506
- Report date
- Feb 16, 2022
- Product type
- Drugs
- Recall number
- D-0538-2022
- Classification
- Class II
- Recalling firm
- ULTRAtab Laboratories, Inc.
- Product quantity
- 50,585,623 tablets
- Termination date
- Jan 7, 2025
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- HPC Tablet (Acetaminophen 110 mg, Aspirin 162 mg, Caffeine 32.4 mg, Salicylamide 152 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62969-242-00
- 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