FDA recall D-1608-2020

Product

WP Thyroid, Westhroid Pure, 3/4 Grain (48.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5650-2 ; b) 30 Tablets, NDC 64727-5650-4; c) 60 Tablets, NDC 64727-5650-5; d) 90 Tablets, NDC 64727-5650-6; e) 100 Tablets, NDC 64727-5650-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034

Reason for recall

CGMP Deviations: manufactured under the same conditions as those found to be subpotent.

Distribution

Nationwide in the United States

Key facts

Status

Terminated

Initiation date

2020-08-25

Report date

2020-09-23

Termination date

2023-11-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Phoenix, AZ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1608-2020