Drug product
Avicel PH-102 NF, Microcrystalline Cellulose NF, 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.
D-0545-2023
Product summary
- Event
- Event 92120
- Status
- Terminated
- Classification
- Class III
- Quantity
- 320,350 kg in bulk drums, boxes & sacks
- Official record key
drug-enforcement:D-0545-2023
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Code information: Batch Numbers: P220834360, P220834366, P220834383, P220834440, P220834460, 2173755143, 2173771316, 2173773188, P220834401, P220834403, P220834482, P220834505, P220834543, P220834545
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.
Derived failure modes
-
Potency or specification failure
Out of specification