Class III · Low risk
Avicel PH-200 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Avicel DG
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Avicel DG, MCC/Dibasic Calcium Phosphate, 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; Manufactured in USA; Headquarters: DuPont Nutrition Biosciences ApS, Langebrogade 1, Copenhagen, Denmark.
- Recalling firm
- DuPont Nutrition USA, Inc
- Origin
- DE, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0547-2023 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by DuPont Nutrition USA, Inc
All 2023 recalls
Class III · Low risk
Avicel PH-102 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Avicel PH-101 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Class III · Low risk
Bd-102 Nf
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Other impurity / degradation recalls from 2023
All impurity / degradation recalls
Class III · Low risk
Eprontia (topiramate)
Failed Impurities/Degradation Specifications: Out of specification Impurity C (4,5-desisopropylidene topiramate) result observed during routine stability testing at 18 months.
Class II · Moderate risk
Liothyronine Sodium Tablets
Failed Impurities/Degradation Specifications
Class II · Moderate risk
KinderMed INFANTS' PAIN & FEVER Acetaminophen
Failed Impurities/Degradation Specifications
Class II · Moderate risk
KinderMed KIDS' PAIN & FEVER Acetaminophen
Failed Impurities/Degradation Specifications
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