Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
SigmaPharm Laboratories
Class I - Dangerous
Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
Class I - Dangerous
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class I - Dangerous
Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
Class I - Dangerous
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 manufactured product.