Status
Terminated
Drug Enforcement D-0352-2023
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Classification
Class III
Report Date
March 8, 2023
Termination Date
December 20, 2023
Product Information
- Product description
- BD-102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp., 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. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark
- Product quantity
- 106,560 kg. polyethylene lined fiber 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
- 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
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-0352-2023
- Event ID
- 91616
- Recall initiation date
- February 1, 2023
- Center classification date
- February 24, 2023
- Code info
- Batch # 2173784100, B220834549 These excipients are noted not to have an expiration date.
- More code info
- —