Reported Sep 1, 2021 · Terminated
Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC…
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 bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
- Lot codes and dates
- Lot Numbers
181300118131011813201EXP. May 202318226011822701EXP Nov 202319057011905801190650119066011906701EXP May 2024
- Lot Numbers
- Amount recalled
- 1,993 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Impurities 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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