Why it was recalled
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Product description
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
Lot numbers, UPCs & expiration codes
Lot Numbers: 1813001, 1813101, 1813201, EXP. May 2023; 1822601, 1822701, EXP Nov 2023; 1905701, 1905801, 1906501, 1906601, 1906701, EXP May 2024
Where it was sold
Disttibuted 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-0766-2021
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Aug 13, 2021
- FDA report date
- Sep 1, 2021
- Quantity
- 1,993 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- SigmaPharm Laboratories LLC
Original FDA data
Every field from FDA enforcement report D-0766-2021, exactly as published.
Show all FDA fields
- City
- Bensalem
- State
- PA
- Status
- Terminated
- Country
- United States
- Event ID
- 88474
- Address
- 3375 Progress Dr
- Code information
- Lot Numbers: 1813001, 1813101, 1813201, EXP. May 2023; 1822601, 1822701, EXP Nov 2023; 1905701, 1905801, 1906501, 1906601, 1906701, EXP May 2024
- Postal code
- 19020-5801
- Report date
- Sep 1, 2021
- Product type
- Drugs
- Recall number
- D-0766-2021
- Classification
- Class II
- Recalling firm
- SigmaPharm Laboratories LLC
- Product quantity
- 1,993 bottles
- Termination date
- Sep 26, 2022
- Reason for recall
- Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
- Distribution pattern
- Disttibuted Nationwide in the USA.
- Recall initiation date
- Aug 13, 2021
- Initial firm notification
- Letter
- Center classification date
- Aug 24, 2021