Sigmapharm Laboratories
Home | Sigmapharm Laboratories, LLC
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 .
- Type
- Manufacturer
- Location
- Mexico
- Website
- http://sigmapharm.com
- Categories
- Pharmaceutical Manufacturing
Listed in a source registry
Verified facts
- domain-registered (green), checked 2026-08-02 Domain registry record
Import rules for these goods
- Medicines imported into the EU must come from a site holding an EU GMP certificate, and the importer needs a manufacturing/import authorisation. European Medicines Agency (GMP)