Recalls / Class III
Class IIID-0545-2023
Product
Avicel PH-102 NF, Microcrystalline Cellulose NF, 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; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.
- Affected lot / code info
- Batch Numbers: P220834360, P220834366, P220834383, P220834440, P220834460, 2173755143, 2173771316, 2173773188, P220834401, P220834403, P220834482, P220834505, P220834543, P220834545
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results obtained 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
- 320,350 kg in bulk drums, boxes & sacks
- Distribution pattern
- Nationwide in the USA, Malta, Canada, China, Peru, Mexico, Australia, Saudi Arabia, Spain, Dominican Republic, Puerto Rico, Singapore, Bangkok, Ireland, India, and Columbia.
Timeline
- Recall initiated
- 2023-04-13
- FDA classified
- 2023-04-25
- Posted by FDA
- 2023-05-03
- Terminated
- 2024-03-04
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0545-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.