Status
Terminated
Drug Enforcement D-0544-2023
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Classification
Class III
Report Date
May 3, 2023
Termination Date
March 4, 2024
Product Information
- Product description
- Avicel PH-101 NF, Microcrystalline Cellulose NF, 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; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.
- Product quantity
- 464,050 kg in bulk drums, boxes & sacks
- Reason for recall
- Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- 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.
Location & Firm
- Recalling firm
- DuPont Nutrition USA, Inc
- Address
-
1301 Ogletown Rd, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0544-2023
- Event ID
- 92120
- Recall initiation date
- April 13, 2023
- Center classification date
- April 25, 2023
- Code info
- Batch Numbers: 2173809472, 2173811313, P120834282, P120834305, P120834313, P120834324, P120834423, P120834437, P120834443, P120834478, 2173739298, 2173740020, 2173771315, P120834254, P120834476
- More code info
- —