Why it was recalled
CGMP Deviations
Product description
Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00
Lot numbers, UPCs & expiration codes
Product Codes: M800L Bulk Lots: 18K005, 18K075, 18K098, 18M064, 19C021, 19C050, 19G081, 19G082, 19H012, 19H013, 19J036, 19J037
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-0553-2022
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Jan 26, 2022
- FDA report date
- Feb 16, 2022
- Quantity
- 25,769,495 tablets
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ULTRAtab Laboratories, Inc.
Original FDA data
Every field from FDA enforcement report D-0553-2022, 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: M800L Bulk Lots: 18K005, 18K075, 18K098, 18M064, 19C021, 19C050, 19G081, 19G082, 19H012, 19H013, 19J036, 19J037
- Postal code
- 12528-1506
- Report date
- Feb 16, 2022
- Product type
- Drugs
- Recall number
- D-0553-2022
- Classification
- Class II
- Recalling firm
- ULTRAtab Laboratories, Inc.
- Product quantity
- 25,769,495 tablets
- Termination date
- Jan 7, 2025
- Reason for recall
- CGMP Deviations
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Coated Back Relief Tablet (Acetaminophen 250 mg, Magnesium Salicylate 290 mg, Caffeine 50 mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-800-00
- 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