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Recall Observatory FDA recall evidence

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

August 05, 2021

Class III

Product summary

Firm
DuPont Nutrition USA, Inc
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

    reason.potency_specification_failure · v1.0.0

    Out of specification