Acella Pharmaceuticals, LLC: Drug Recall

Recall #D-0399-2021 · 04/29/2021

Class I: Dangerous

Recall Details

Recall Number: D-0399-2021
Classification: Class I
Product Type: Drug
Recalling Firm: Acella Pharmaceuticals, LLC
Status: Terminated
Date Initiated: 04/29/2021
Location: Alpharetta, GA, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: a) 69,289 bottles; b) 9,076 bottles

Reason for Recall

Subpotent Drug

Product Description

NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-count bottles (NDC 42192-328-07) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005

Distribution Pattern

Nationwide within the United States including Puerto Rico

Other Recalls by Acella Pharmaceuticals, LLC

Class II: Risk 09/29/2025

Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Class III: Low Risk 04/24/2024

Subpotent drug
Class III: Low Risk 11/14/2022

Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
Class III: Low Risk 11/14/2022

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class III: Low Risk 11/14/2022

Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.

View all recalls by Acella Pharmaceuticals, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.