Avicel PH- 102 NF, Microcrystalline Cellulose, NF, Ph. Eur., Jp, Net Content/Gross Weight 20.0 KG...

FDA Drug Recall #D-0350-2023 — Class III — February 1, 2023

Recall Summary

Recall Number D-0350-2023
Classification Class III — Low risk
Date Initiated February 1, 2023
Status Terminated
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm DuPont Nutrition USA, Inc
Location Newark, DE
Product Type Drugs
Quantity 368,980 kg polyethylene lined fiber drums, boxes & sacks

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

Reason for Recall

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

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

Lot / Code Information

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.

Other Recalls from DuPont Nutrition USA, Inc

Recall # Classification Product Date
D-0546-2023 Class III Avicel PH-200 NF, Microcrystalline Cellulose NF... Apr 13, 2023
D-0547-2023 Class III Avicel DG, MCC/Dibasic Calcium Phosphate, Net C... Apr 13, 2023
D-0545-2023 Class III Avicel PH-102 NF, Microcrystalline Cellulose NF... Apr 13, 2023
D-0544-2023 Class III Avicel PH-101 NF, Microcrystalline Cellulose NF... Apr 13, 2023
D-0352-2023 Class III BD-102 NF, Microcrystalline Cellulose, NF, Ph. ... Feb 1, 2023

Frequently Asked Questions

Nitrosamines are probable human carcinogens — they can increase cancer risk with long-term exposure above certain thresholds, but they do not cause immediate harm from taking a single dose. The FDA calculates an acceptable daily intake (ADI) for each nitrosamine compound, and recalls are triggered when levels exceed this threshold. If you have been taking a recalled product, the FDA generally advises against abruptly stopping your medication (especially for critical conditions like blood pressure or diabetes) until you consult your doctor. The incremental cancer risk from short-term exposure is very small.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.