Drug product
Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
D-0728-2021
Product summary
- Event
- Event 88428
- Status
- Terminated
- Classification
- Class III
- Quantity
- 2,384,720 kg
- Official record key
drug-enforcement:D-0728-2021
Official wording
Reason: Out of specification results for conductivity.
Code information: Lot Numbers: P120834253, PN20834314, PN20834326, P220834329, P120834471, 2173728724, 2173731307, 2173739294, 2173742956, 2173743721, 2173747040 217374970, 2173749846, 2173751395, 2173751995, 2173753080, 2173749460, 2173755135, 2173755142, 2173758869, 22173758869 2173759101, 2173759087, 2173760958, 21737606959, 2173762248, 217376233, 2173763871 2173763872, 2173755139, 2173763875, 2173764734, 2173763870, 2173764735, 2173769670, 2173775381, 2173776518, 217377536, 2173779284, 2173800414, 2173801736, 2173801737, 2173802516, 2173805796, 2173805797, 2173806449, 2173806450, 2173809474, 2173809473 2173810873, 2173811314, 2173811315, 2173806441, 217381169, 2173811666 These excipients are noted not to have an expiration date.
Distribution pattern: Product was distributed nationwide, including Puerto Rico and to foreign accounts abroad.
Derived failure modes
-
Potency or specification failure
Out of specification