Class III Terminated

Avicel PH- 101 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp. Net Content/Gross Weight 50.0 KG / 54.5 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

Company: Dupont Nutrition Usa, Inc
Recall Initiated: February 1, 2023
Posted: March 8, 2023
Recall Number: D-0349-2023
Voluntary / Mandated: Voluntary: Firm initiated
Quantity: 131,060 kg. polyethylene lined fiber drums, boxes & sacks
Firm Location: Newark, DE, United States

Reason for Recall

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

Distribution

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

Lot / Code Info

Batch # 2173763874, 2173771315, P120834254, P120834263, P120834267, P120834275, P120834441, P120834442, P120834472, P120834507, P120834517, P120834518, P120834519, P120834520, These excipients are noted not to have an expiration date.