Bensalem, PA, United States
SigmaPharm Laboratories LLC recalls
3 recalls recorded since 2018, most recently on 21 September 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)0
Terminated or completed3
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 21 September 2021
- Terminated
- 26 September 2022
- Reason
- Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0898-2021
- Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in case packs containing 2 bottles. Sigmapharm Laboratories, LLC, Bensalem, PA 19020, NDC 4
Terminated Class II Drugs
- Recall started
- 13 August 2021
- Terminated
- 26 September 2022
- Reason
- Failed Impurities Specifications: Out of Specification impurity results obtained during routine testing.
- Distribution
- Disttibuted Nationwide in the USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0766-2021
- Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 19020 NDC 42794-086-14 UPC Code# 3 42794 086 14 4
Terminated Class III Drugs
- Recall started
- 19 April 2021
- Terminated
- 26 September 2022
- Reason
- Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flavoring agent instead of Art Black Cherry Flavor flavoring agent
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0379-2021, D-0380-2021
- Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020 NDC 42794-016-10.
- Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, 19020, NDC 42794-017-10
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.