Drug product
Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. 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. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark
D-0349-2023
Product summary
- Event
- Event 91616
- Status
- Terminated
- Classification
- Class III
- Quantity
- 131,060 kg. polyethylene lined fiber drums, boxes & sacks
- Official record key
drug-enforcement:D-0349-2023
Official wording
Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Code information: Batch # 2173763874, 2173771315, P120834254, P120834263, P120834267, P120834275, P120834441, P120834442, P120834472, P120834507, P120834517, P120834518, P120834519, P120834520, 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