Drug product
Nature-Throid 1 GR (65 mg), Each Tablet Contains: Thyroid USP 1 GR (65 mg), Liothyronine (T3) 9 mcg, Levothyroxine (T4) 38 mcg, 100 Tablets per bottle, Rx Only, Pkg By PD-Rx Pharmaceuticals Incorporated, Oklahoma City, OK 73127, NDC 43063-819-01.
D-0005-2021
Product summary
- Event
- Event 86533
- Status
- Terminated
- Classification
- Class II
- Quantity
- 20 bottles
- Official record key
drug-enforcement:D-0005-2021
Official wording
Reason: CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
Code information: Lot #: J18C68 Exp. 10/31/20
Distribution pattern: AZ, OK
Derived failure modes
-
Manufacturing or process control
CGMP deviations