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SigmaPharm Laboratories LLC FDA Recalls
4 recalls on file across drugs, 0 of them Class I and 0 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton Class IISep 21, 2021Failed Impurities/Degradation Specifications; Out of Specifi |
| Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-1Class IIAug 13, 2021Failed Impurities Specifications: Out of Specification impur |
| Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-Class IIIApr 19, 2021Incorrect Product Formulation; product was manufactured with |
| Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794Class IIIApr 19, 2021Incorrect Product Formulation; product was manufactured with |