SigmaPharm Laboratories LLC
FDA Regulatory Profile
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 0
- Inspections
- 12
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0898-2021 | Class II | Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps | September 21, 2021 |
| D-0766-2021 | Class II | Sodium Phenylbutyrate POWDER, 250 grams bottle, Rx Only, Sigmapharm Laboratories, LLC Bensalem, PA 1 | August 13, 2021 |
| D-0379-2021 | Class III | Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA, | April 19, 2021 |
| D-0380-2021 | Class III | Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laboratories, LLC, Bensalem, PA | April 19, 2021 |
| D-1344-2014 | Class II | Liothyronine Sodium Tablets, USP 5 mcg, Rx Only, a) 100-count bottle NDC 42794-018-02 and b) 1000-co | April 22, 2014 |