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Recall Observatory FDA recall evidence

Drug product

Nature-Throid, 1/2 Grain, 32.5 mg (Thyroid U.S.P. 1/2 gr. (32.5 mg)/Liothyronine (T3) 4.5mcg/Levothyroxine (T4) 19mch, 100-count tablets, Rx Only, Mfg: RLC Labs; Cave Creek, AZ, Preferred Pharmaceuticals, Inc. NDC 68788-9283-01

D-1621-2020

September 02, 2020

Class II

Product summary

Firm
Preferred Pharmaceuticals, Inc.
Event
Event 86394
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
drug-enforcement:D-1621-2020

Official wording

Reason: CGMP Deviations

Code information: Lot #: L2717G, Exp. Date: 12/31/2020; Lot #: B2618A, Exp. Date: 12/21/2020; Lot #: C1419P, Exp. Date: 2/28/2021

Distribution pattern: Repackaged tablets sold to three physicians located in CA and GA.

Derived failure modes

  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    CGMP Deviations