SigmaPharm Laboratories recalls
FDA enforcement reports naming SigmaPharm Laboratories LLC as the recalling firm.
- Recall reports
- 5
- Class I (serious)
- 0
- Most recent report
- Oct 6, 2021
- Oct 6, 2021Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 5…Drug · SigmaPharm Laboratories LLCFailed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.Class II
- Sep 1, 2021Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC B…Drug · SigmaPharm Laboratories LLCFailed Impurities Specifications: Out of Specification impurity results obtained during routine testing.Class II
- May 26, 2021Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC,…Drug · SigmaPharm Laboratories LLCIncorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agentClass III
- May 26, 2021Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC,…Drug · SigmaPharm Laboratories LLCIncorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agentClass III
- May 28, 2014Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 a…Drug · SigmaPharm Laboratories LLCCross 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.Class II