Recalls / Class III
Class IIID-0728-2021
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
- Affected lot / code info
- 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.
Why it was recalled
Out of specification results for conductivity.
Recalling firm
- Firm
- DuPont Nutrition USA, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1301 Ogletown Rd, N/A, Newark, Delaware 19711-5419
Distribution
- Quantity
- 2,384,720 kg
- Distribution pattern
- Product was distributed nationwide, including Puerto Rico and to foreign accounts abroad.
Timeline
- Recall initiated
- 2021-08-05
- FDA classified
- 2021-08-16
- Posted by FDA
- 2021-08-25
- Terminated
- 2023-03-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0728-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.