Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Product description
Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.
Lot numbers, UPCs & expiration codes
Batch Numbers: 2213749659, 2213766837, 2213776558, 2213776559
Where it was sold
Nationwide in the USA, Malta, Canada, China, Peru, Mexico, Australia, Saudi Arabia, Spain, Dominican Republic, Puerto Rico, Singapore, Bangkok, Ireland, India, and Columbia.
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-0547-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Apr 13, 2023
- FDA report date
- May 3, 2023
- Quantity
- 23,060 kg in bulk drums, boxes & sacks
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- DuPont Nutrition USA, Inc
Original FDA data
Every field from FDA enforcement report D-0547-2023, exactly as published.
Show all FDA fields
- City
- Newark
- State
- DE
- Status
- Terminated
- Country
- United States
- Event ID
- 92120
- Address
- 1301 Ogletown Rd
- Code information
- Batch Numbers: 2213749659, 2213766837, 2213776558, 2213776559
- Postal code
- 19711-5419
- Report date
- May 3, 2023
- Product type
- Drugs
- Recall number
- D-0547-2023
- Classification
- Class III
- Recalling firm
- DuPont Nutrition USA, Inc
- Product quantity
- 23,060 kg in bulk drums, boxes & sacks
- Termination date
- Mar 4, 2024
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Avicel DG, MCC/Dibasic Calcium Phosphate, Net Content/Gross Weight 20.0 KG / 21.1 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.
- Distribution pattern
- Nationwide in the USA, Malta, Canada, China, Peru, Mexico, Australia, Saudi Arabia, Spain, Dominican Republic, Puerto Rico, Singapore, Bangkok, Ireland, India, and Columbia.
- Recall initiation date
- Apr 13, 2023
- Initial firm notification
- Letter
- Center classification date
- Apr 25, 2023