Drug product
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
D-0351-2023
Product summary
- Event
- Event 91616
- Status
- Terminated
- Classification
- Class III
- Quantity
- 7,740 kg polyethylene lined fiber drums, boxes & sacks
- Official record key
drug-enforcement:D-0351-2023
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Code information: Batch # PN20834322, PN20834335 These excipients are noted not to have an expiration date.
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
Derived failure modes
-
Potency or specification failure
Out of specification