Sigmapharm Laboratories, LLC, a privately held specialty pharmaceutical company, develops, manufactures and markets unique Generic and Branded products often unmatched by competitors.
Sigmapharm initiates a Voluntary Recall at the Retail Level for its drug product, Sodium Phenylbutyrate Powder, 250 Grams. This recall has been initiated due to the out of-specification (OOS) impurity results obtained during routine quality testing of a stability sample for one lot of Sodium Phenylbutyrate Powder, 250 Grams. This recall is being extended to all other potentially impacted lots as mentioned in the attached Recall letters dated August 13, 2021 and September 21, 2021.
Sigmapharm relaunches its generic Ultramicrosize Griseofulvin Tablets, USP 125 mg and 250 mg, exclusively under its own label.
Sigmapharm relaunches its generic Amiloride Hydrochloride Tablets, USP 5 mg, exclusively under its own label.