Drug Enforcement D-0349-2023

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

Status

Terminated

Classification

Class III

Report Date

March 8, 2023

Termination Date

December 20, 2023

Product Information

Product description
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
Product quantity
131,060 kg. polyethylene lined fiber drums, boxes & sacks
Reason for recall
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Recall initiation reason
—
Initial firm notification
Letter
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

Location & Firm

Recalling firm
DuPont Nutrition USA, Inc
Address
1301 Ogletown Rd, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0349-2023
Event ID
91616
Recall initiation date
February 1, 2023
Center classification date
February 24, 2023
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.
More code info
—