D-0351-2023 Class III Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- March 8, 2023
- Initiation Date
- February 1, 2023
- Termination Date
- December 20, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 7,740 kg polyethylene lined fiber drums, boxes & sacks
Product Description
Avicel PH-200 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
Reason for Recall
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
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
Code Information
Batch # PN20834322, PN20834335 These excipients are noted not to have an expiration date.