Avicel PH-200 pharmaceutical excipient recalled for failed conductivity specification
DuPont is recalling Avicel PH-200, a pharmaceutical excipient, because test results showed conductivity out of specification. No illnesses or injuries have been reported.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: FDA Class III recall with no reported illnesses or injuries and no described harm to consumers; the issue is a failed conductivity specification in a pharmaceutical excipient with no identified safety impact.
Plain-English summary
DuPont Nutrition USA, Inc. is recalling Avicel PH-200 NF (microcrystalline cellulose), a pharmaceutical excipient used as an inactive ingredient in drug manufacturing. Batches PN20834322 and PN20834335 were recalled because test results showed conductivity out of specification.
The recalled product, totaling approximately 7,740 kilograms in polyethylene-lined fiber drums, boxes, and sacks, was distributed nationwide in the United States and Puerto Rico and to 19 countries: Argentina, Australia, Brazil, Canada, Chile, China, Colombia, Dominican Republic, Germany, India, Ireland, Malaysia, Mexico, Oman, Pakistan, Singapore, South Korea, and Thailand.
No illnesses or injuries have been reported in connection with this recall. The manufacturer notes that this excipient product does not have an expiration date.
The recalled product
- Product
- Avicel PH-200 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, 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. Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copen
- Manufacturer
- DuPont Nutrition USA, Inc
- Category
- Drug — Pharmaceutical Excipient
- Hazard
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 (2)
- Batch # PN20834322
- PN20834335 These excipients are noted not to have an expiration date.
Distribution
Part of a larger recall action
This product is one of 4 recalled by DuPont Nutrition USA, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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