Drug product
Nature-Throid, 1 Grain, 65 mg (Thyroid U.S.P. 1 gr. (65mg)/Liothyronine (T3) 9mcg/Levothyroxine (T4) 38mcg, packaged in a) 90-count bottles (NDC 68788-7604-09), b) 100-count tablets (NDC 68788-7604-01), Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc.
D-1623-2020
Product summary
- Event
- Event 86394
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1623-2020
Official wording
Reason: CGMP Deviations
Code information: a) Lot #: A0220Q, Exp. Date: 10/31/2020; b) Lot #: K15171, Exp. Date: 10/31/2020
Distribution pattern: Repackaged tablets sold to three physicians located in CA and GA.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations