Home / Recalls / Acella Pharmaceuticals, LLC / D-0395-2021

D-0395-2021 Class I Terminated

Recalled by Acella Pharmaceuticals, LLC — Alpharetta, GA

Recall Details

Product Type
Drugs
Report Date
June 2, 2021
Initiation Date
April 29, 2021
Termination Date
March 13, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
a) 66,155 bottles; b) 26,212 bottles

Product Description

NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 42192-327-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

Reason for Recall

Subpotent Drug

Distribution Pattern

Nationwide within the United States including Puerto Rico

Code Information

Lots: a) M327D20-1, M327D20-3 Exp. 03/31/2022, M327H19-3A Exp. 07/31/2021, M327L19-1 Exp. 04/30/2021; b) M327D20-1 Exp. 03/31/2022

Other recalls by Acella Pharmaceuticals, LLC

  • D-0014-2026 Class II — Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed (September 29, 2025)
  • D-0490-2024 Class III — Sodium Sulfacetamide 10% - Sulfur 5% Cleanser, Rx Only, 6 oz (170.3 g) Bottle, M (April 24, 2024)
  • D-0070-2023 Class III — Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x (November 14, 2022)
  • D-0069-2023 Class III — Phenytoin Sodium Injection, USP 100 mg/2 mL, NDC 42192-614-02, packaged in 10 x (November 14, 2022)
  • D-0074-2023 Class III — Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing (November 14, 2022)
  • D-0397-2021 Class I — NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Ma (April 29, 2021)
  • D-0398-2021 Class I — NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx onl (April 29, 2021)
  • D-0396-2021 Class I — NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count b (April 29, 2021)
  • D-0399-2021 Class I — NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count b (April 29, 2021)
  • D-0035-2021 Class I — NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, (September 17, 2020)