Class III · Low risk
Avicel DG
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
Avicel
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Out of specification results for conductivity.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH200 NF, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
- Recalling firm
- DuPont Nutrition USA, Inc
- Origin
- DE, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0728-2021 · 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 2021 recalls
Class III · Low risk
Avicel PH-200 NF
Failed Impurities/Degradation Specifications: Out of specification results obtained for conductivity.
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.
Other failed specification recalls from 2021
All failed specification recalls
Class II · Moderate risk
Buprenorphine HCl
Crystallization; identified as Buprenorphine free base
Class II · Moderate risk
VANComycin 1g added to 250mL of 0.9% Sodium Chloride
Crystallization: Product appears to be turbid.
Class III · Low risk
Topiramate Tablets
Discoloration
Class II · Moderate risk
Pregabalin Capsules
Failed Tablet/Capsule Specifications: Out of Specification results for particle Size Distribution and Bulk Density of the Active Pharmaceutical Ingredient.
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