Recalls / Class II
Class IID-0005-2021
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.
- Affected lot / code info
- Lot #: J18C68 Exp. 10/31/20
Why it was recalled
CGMP deviations; repackaged product was recalled by the manufacturer because it was manufactured under the same conditions as products found to be sub-potent.
Recalling firm
- Firm
- PD-Rx Pharmaceuticals, Inc.
- Notification channel
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Type
- Voluntary: Firm initiated
- Address
- 727 N Ann Arbor Ave, N/A, Oklahoma City, Oklahoma 73127-5822
Distribution
- Quantity
- 20 bottles
- Distribution pattern
- AZ, OK
Timeline
- Recall initiated
- 2020-09-17
- FDA classified
- 2020-10-02
- Posted by FDA
- 2020-10-14
- Terminated
- 2021-11-05
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0005-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.