Microcrystalline Cellulose Pharmaceutical Excipient Recalled for Specification Failure
DuPont Nutrition USA is recalling BD-102 NF Microcrystalline Cellulose, a pharmaceutical excipient, due to failed conductivity specifications. Affected batches were distributed nationwide and internationally for use in drug manufacturing.
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: FDA Class III designation with no reported illnesses or injuries. The hazard is a conductivity specification failure detected during quality control of a pharmaceutical ingredient, representing a manufacturing specification issue rather than a confirmed safety hazard to end users.
Plain-English summary
DuPont Nutrition USA, Inc. is recalling BD-102 NF Microcrystalline Cellulose, a pharmaceutical excipient distributed in bulk containers totaling 106,560 kg in polyethylene-lined fiber drums, boxes, and sacks. The product is manufactured in Newark, Delaware, with headquarters in Copenhagen, Denmark.
The recall was initiated because the product failed to meet impurities and degradation specifications. Conductivity test results were out of specification for affected batches numbered 2173784100 and B220834549.
The affected product was distributed nationwide in the United States and Puerto Rico, as well as internationally to Australia, China, Canada, Colombia, Mexico, Brazil, Malaysia, Chile, Dominican Republic, Singapore, Thailand, Ireland, Germany, South Korea, Argentina, Pakistan, Oman, and India. The product is used as an ingredient in pharmaceutical manufacturing.
The recalled product
- Product
- BD-102 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, Copenhagen,
- Manufacturer
- DuPont Nutrition USA, Inc
- Category
- Drug — Pharmaceutical Excipient
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 # 2173784100
- B220834549 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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