FDA recall D-0005-2021

PD-Rx Pharmaceuticals, Inc. · Class II · 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.

Reason for recall

CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.

Distribution

AZ, OK

Key facts

Status
Terminated
Initiation date
2020-09-17
Report date
2020-10-14
Termination date
2021-11-05
Voluntary/Mandated
Voluntary: Firm initiated
Location
Oklahoma City, OK, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0005-2021