Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Product description
Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark
Lot numbers, UPCs & expiration codes
Batch # 2173763874, 2173771315, P120834254, P120834263, P120834267, P120834275, P120834441, P120834442, P120834472, P120834507, P120834517, P120834518, P120834519, P120834520, These excipients are noted not to have an expiration date.
Where it was sold
Product was distributed nationwide in the United States and Puerto Rico, and to Australia, China, Canada, Columbia, Mexico, Brazil, Malaysia, Chile, Dominic Republic, Singapore, Thailand, Ireland, Germany, South Korea, Argentina, Pakistan, Oman, India
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-0349-2023
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 1, 2023
- FDA report date
- Mar 8, 2023
- Quantity
- 131,060 kg. polyethylene lined fiber drums, boxes & sacks
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- DuPont Nutrition USA, Inc
Original FDA data
Every field from FDA enforcement report D-0349-2023, exactly as published.
Show all FDA fields
- City
- Newark
- State
- DE
- Status
- Terminated
- Country
- United States
- Event ID
- 91616
- Address
- 1301 Ogletown Rd
- Code information
- Batch # 2173763874, 2173771315, P120834254, P120834263, P120834267, P120834275, P120834441, P120834442, P120834472, P120834507, P120834517, P120834518, P120834519, P120834520, These excipients are noted not to have an expiration date.
- Postal code
- 19711-5419
- Report date
- Mar 8, 2023
- Product type
- Drugs
- Recall number
- D-0349-2023
- Classification
- Class III
- Recalling firm
- DuPont Nutrition USA, Inc
- Product quantity
- 131,060 kg. polyethylene lined fiber drums, boxes & sacks
- Termination date
- Dec 20, 2023
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight 50.0 KG / 54.5 KG bulk container, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711, USA. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark
- Distribution pattern
- Product was distributed nationwide in the United States and Puerto Rico, and to Australia, China, Canada, Columbia, Mexico, Brazil, Malaysia, Chile, Dominic Republic, Singapore, Thailand, Ireland, Germany, South Korea, Argentina, Pakistan, Oman, India
- Recall initiation date
- Feb 1, 2023
- Initial firm notification
- Letter
- Center classification date
- Feb 24, 2023