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Recall Observatory FDA recall evidence

Drug 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, Copenhagen, Denmark

D-0351-2023

February 01, 2023

Class III

Product summary

Firm
DuPont Nutrition USA, Inc
Event
Event 91616
Status
Terminated
Classification
Class III
Quantity
7,740 kg polyethylene lined fiber drums, boxes & sacks
Official record key
drug-enforcement:D-0351-2023

Official wording

Reason: Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.

Code information: Batch # PN20834322, PN20834335 These excipients are noted not to have an expiration date.

Distribution pattern: 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

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Out of specification