Recalls / Class II
Class IID-0766-2021
Product
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
- Brand name
- Sodium Phenylbutyrate
- Generic name
- Sodium Phenylbutyrate
- Active ingredient
- Sodium Phenylbutyrate
- Route
- Oral
- NDC
- 42794-086
- FDA application
- ANDA202819
- Affected lot / code info
- Lot Numbers: 1813001, 1813101, 1813201, EXP. May 2023; 1822601, 1822701, EXP Nov 2023; 1905701, 1905801, 1906501, 1906601, 1906701, EXP May 2024
Why it was recalled
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Recalling firm
- Firm
- SigmaPharm Laboratories LLC
- Manufacturer
- Sigmapharm Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 3375 Progress Dr, N/A, Bensalem, Pennsylvania 19020-5801
Distribution
- Quantity
- 1,993 bottles
- Distribution pattern
- Disttibuted Nationwide in the USA.
Timeline
- Recall initiated
- 2021-08-13
- FDA classified
- 2021-08-24
- Posted by FDA
- 2021-09-01
- Terminated
- 2022-09-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0766-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.