Home / Recalls / Acella Pharmaceuticals, LLC / D-0036-2021

D-0036-2021 Class I Terminated

Recalled by Acella Pharmaceuticals, LLC — Alpharetta, GA

Recall Details

Product Type
Drugs
Report Date
October 28, 2020
Initiation Date
September 17, 2020
Termination Date
December 8, 2022
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
9816 bottles

Product Description

NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-328-01

Reason for Recall

Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.

Distribution Pattern

Nationwide within the United States

Code Information

Lot #: M328F19-3 Exp. 11/2020

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-0074-2023 Class III — Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads, Net weight 3.7g (60 cleansing (November 14, 2022)
  • 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-0397-2021 Class I — NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Ma (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-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-0399-2021 Class I — NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count b (April 29, 2021)
  • D-0395-2021 Class I — NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count b (April 29, 2021)