Why it was recalled
Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
Product description
Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
Lot numbers, UPCs & expiration codes
Lot # 2173766940
Where it was sold
Product was distributed to one account that may have used it as a component in finished drug formulations, and further distributed Nationwide in the USA.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0830-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Aug 27, 2021
- FDA report date
- Sep 29, 2021
- Quantity
- 80 kg
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- DuPont Nutrition USA, Inc
Original FDA data
Every field from FDA enforcement report D-0830-2021, exactly as published.
Show all FDA fields
- City
- Newark
- State
- DE
- Status
- Terminated
- Country
- United States
- Event ID
- 88617
- Address
- 1301 Ogletown Rd
- Code information
- Lot # 2173766940
- Postal code
- 19711-5419
- Report date
- Sep 29, 2021
- Product type
- Drugs
- Recall number
- D-0830-2021
- Classification
- Class I
- Recalling firm
- DuPont Nutrition USA, Inc
- Product quantity
- 80 kg
- Termination date
- Mar 11, 2022
- Reason for recall
- Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total aerobic microbial count (TAMC).
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG drum, Manufactured by: DuPont Nutrition USA, Inc., 1301 Ogletown Road, Newark, DE 19711
- Distribution pattern
- Product was distributed to one account that may have used it as a component in finished drug formulations, and further distributed Nationwide in the USA.
- Recall initiation date
- Aug 27, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 23, 2021