Recalls / Class II
Class IID-0898-2021
Product
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
- Brand name
- Sodium Phenylbutyrate
- Generic name
- Sodium Phenylbutyrate
- Active ingredient
- Sodium Phenylbutyrate
- Route
- Oral
- NDC
- 42794-086
- FDA application
- ANDA202819
- Affected lot / code info
- Lots 2005401, 2005501, 2005601, 2005701, Exp FEB 2023; Lots 2101401, 2101501, Exp FEB-2024
Why it was recalled
Failed Impurities/Degradation 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
- 1192 bottles
- Distribution pattern
- Nationwide
Timeline
- Recall initiated
- 2021-09-21
- FDA classified
- 2021-09-30
- Posted by FDA
- 2021-10-06
- Terminated
- 2022-09-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0898-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.