Why it was recalled
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Product description
Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14
Lot numbers, UPCs & expiration codes
Lots 2005401, 2005501, 2005601, 2005701, Exp FEB 2023; Lots 2101401, 2101501, Exp FEB-2024
Where it was sold
Nationwide
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-0898-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Sep 21, 2021
- FDA report date
- Oct 6, 2021
- Quantity
- 1192 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SigmaPharm Laboratories LLC
Original FDA data
Every field from FDA enforcement report D-0898-2021, exactly as published.
Show all FDA fields
- City
- Bensalem
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 88736
- Address
- 3375 Progress Dr
- Code information
- Lots 2005401, 2005501, 2005601, 2005701, Exp FEB 2023; Lots 2101401, 2101501, Exp FEB-2024
- Postal code
- 19020-5801
- Report date
- Oct 6, 2021
- Product type
- Drugs
- Recall number
- D-0898-2021
- Classification
- Class II
- Recalling firm
- SigmaPharm Laboratories LLC
- Product quantity
- 1192 bottles
- Termination date
- Sep 26, 2022
- Reason for recall
- Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 42794-086-14
- Distribution pattern
- Nationwide
- Recall initiation date
- Sep 21, 2021
- Initial firm notification
- Letter
- Center classification date
- Sep 30, 2021