Recall Enforment Report D-0036-2021

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Acella Pharmaceuticals, LLC, originally initiated on 09-17-2020 for the product 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 The product was recalled due to subpotent drug: fda analysis found these products to be less than the labeled claim for the levothyroxine (t4) portion of the product.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0036-202109-17-202010-28-2020Class I9816 bottlesNP Thyroid 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-328-01Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.Terminated
D-0035-202109-17-202010-28-2020Class I19,296 bottlesNP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
42192-327Np Thyroid 15 Levothyroxine, LiothyronineTabletOralAcella Pharmaceuticals, LlcHuman Prescription Drug
42192-328Np Thyroid 120 Levothyroxine, LiothyronineTabletOralAcella Pharmaceuticals, LlcHuman Prescription Drug