The Recall Desk
ModerateFDA (Drugs)·D-0546-2023·Announced 2023-05-03

DuPont Avicel PH-200 NF pharmaceutical ingredient recalled for conductivity specification failure

DuPont is recalling Avicel PH-200 NF microcrystalline cellulose, a pharmaceutical ingredient, for failing conductivity specifications. The bulk ingredient was distributed to drug manufacturers in the USA and internationally.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class III pharmaceutical ingredient recall with out-of-specification conductivity results. No illnesses or injuries have been reported. The specification failure could affect pharmaceutical quality but does not indicate an immediate safety hazard.

Plain-English summary

DuPont Nutrition USA, Inc. is recalling Avicel PH-200 NF (microcrystalline cellulose NF), a pharmaceutical ingredient used in drug manufacturing. The recall involves approximately 93,660 kg distributed in bulk containers.

The recall was initiated because quality testing identified out-of-specification conductivity results in the affected batches. This specification failure may impact the quality of pharmaceutical products manufactured with this ingredient.

The affected batches (Batch Numbers: 2173766945, 2173768895, PN20834306, 217373201, PN20834301) were distributed to pharmaceutical manufacturers in the USA and internationally, including Malta, Canada, China, Peru, Mexico, Australia, Saudi Arabia, Spain, the Dominican Republic, Puerto Rico, Singapore, Bangkok, Ireland, India, and Colombia.

The recalled product

Product
Avicel PH-200 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,
Manufacturer
DuPont Nutrition USA, Inc
Hazard
  • specification-failure

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Batch Numbers: 2173766945
  • 2173768895
  • PN20834306
  • 217373201
  • PN20834301

Distribution

Distributed nationwide across the United States.