Acella Pharmaceuticals, LLC

FDA Regulatory Profile

Summary

Total Recalls
15 (10 Class I)
510(k) Clearances
1
Inspections
12
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0014-2026Class IIDoxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella PharmaceSeptember 29, 2025
D-0490-2024Class IIISodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, Manufactured for AcelApril 24, 2024
D-0074-2023Class IIISodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing pads Net weight 3.7November 14, 2022
D-0070-2023Class IIIPhenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per cartNovember 14, 2022
D-0069-2023Class IIIPhenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x 2 mL vials per cartoNovember 14, 2022
D-0395-2021Class INP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-32April 29, 2021
D-0396-2021Class INP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (NDC 42192-32April 29, 2021
D-0397-2021Class INP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: AcelApril 29, 2021
D-0398-2021Class INP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For:April 29, 2021
D-0399-2021Class INP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-32April 29, 2021
D-0035-2021Class INP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: ASeptember 17, 2020
D-0036-2021Class INP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: September 17, 2020
D-1298-2020Class INP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured ForMay 22, 2020
D-1299-2020Class INP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx Only, Manufactured For: May 22, 2020
D-1300-2020Class INP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles, Rx Only, ManufacturedMay 22, 2020

Recent 510(k) Clearances

K-NumberDeviceDate
K120730LOUTREX TOPICAL CREAMSeptember 6, 2012