WP Thyroid recalled over manufacturing violations

Recall date

August 25, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

RLC Labs Inc. recalls WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg], 1/4 Grain (16.25…

Recall number

D-1606-2020

FDA classification

Class II

Brand / firm

RLC Labs Inc.

Sold / distributed

Nationwide in the United States

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

WP Thyroid, Westhroid Pure, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg], 1/4 Grain (16.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-5450-4; b) 60-count bottles, NDC 64727-5450-5; c) 90-count bottles, NDC 64727-5450-6; d) 100-count bottles, NDC 64727-5450-1; and e) 1,000-count bottles, NDC 64727-5450-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.