Drug recall
NP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella…
FDA recall event 86467 · Class I · Acella Pharmaceuticals, LLC
Key facts
| Event ID | 86467 |
|---|---|
| Recall numbers | D-0035-2021, D-0036-2021 |
| Recalling firm | Acella Pharmaceuticals, LLC |
| Product type | Drugs |
| Products | 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, NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01 |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary: Firm Initiated |
| 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. |
| Initiation date | Sep 17, 2020 |
| Report date | Oct 28, 2020 |
| Termination date | Dec 8, 2022 |
| City | Alpharetta |
| State | GA |
| Country | United States |
| FEI number | 3006691461 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: