SigmaPharm Laboratories Sodium Phenylbutyrate Powder, 250 Grams recall — FDA D-0898-2021
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Overview of recall records associated with SigmaPharm Laboratories LLC, including dates, categories and classifications where available.
Classification mix: Class III: 2, Class II: 2.
Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Cross Contamination with Other Products: Four lots of Liothyronine Sodium Tablets, USP 5 mcg are being recalled due to the finding of a potential carryover of trace amounts of a previously…
This page summarizes recall records in which the official source identifies SigmaPharm Laboratories LLC as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.