Recall record at a glance
| Official record | D-0350-2023 |
|---|---|
| Category | Drug Recalls |
| Classification | Class III |
| FDA record status | Terminated |
| Recalling firm | DuPont Nutrition USA, Inc. |
| Report date | Mar 8, 2023 |
| Recall initiation date | Feb 1, 2023 |
| Quantity | 368,980 kg polyethylene lined fiber drums, boxes & sacks |
| Location | Newark, DE, United States |
Official product description
Avicel PH- 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, Denmark
Why the product was recalled
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Distribution information
Product was distributed nationwide in the United States and Puerto Rico, and to Australia, China, Canada, Columbia, Mexico, Brazil, Malaysia, Chile, Dominic Republic, Singapore, Thailand, Ireland, Germany, South Korea, Argentina, Pakistan, Oman, India
How to read the classification
FDA Class III generally covers situations in which use of or exposure to the product is not likely to cause adverse health consequences. The classification displayed here is taken from the FDA enforcement record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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