Recalls / Class III
Class IIID-0350-2023
Product
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
- Affected lot / code info
- Batch # 2173747038, 2173773188, 2173777535, P220834401, P220834402, P220834404, P220834406, P220834422, P220834425, P220834429, P220834430, P220834482, P220834505, P220834508, P220834543, These excipients are noted not to have an expiration date.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Recalling firm
- Firm
- DuPont Nutrition USA, Inc
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1301 Ogletown Rd, N/A, Newark, Delaware 19711-5419
Distribution
- Quantity
- 368,980 kg polyethylene lined fiber drums, boxes & sacks
- 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
Timeline
- Recall initiated
- 2023-02-01
- FDA classified
- 2023-02-24
- Posted by FDA
- 2023-03-08
- Terminated
- 2023-12-20
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0350-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.