Reported Oct 6, 2021 · Terminated
Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton…
SigmaPharm Laboratories LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SigmaPharm Laboratories LLC · 3375 Progress Dr · Bensalem, PA · 19020-5801
Is this the product you have?
- 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 codes and dates
Lots 2005401200550120056012005701Exp FEB 2023Lots 21014012101501Exp FEB-2024
- Amount recalled
- 1192 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
This product could cause temporary or reversible health problems — stop using it.
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