FDA recall D-1619-2020

RLC Labs Inc. · Class I · drug

Product

Nature Throid, 1.5 Grain (97.5 mg) Thyroid USP [Liothyronine (T3) 13.5 mcg, Levothyroxine (T4) 57 mcg], packaged in a) 30-count bottles (NDC 64727-3305-4), b) 60-count bottles (NDC 64727-3305-5), c) 90-count bottles (NDC 64727-3305-6), and 100-count bottles (NDC 64727-3305-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3305-1

Reason for recall

Subpotent Drug: FDA analysis found product 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-1619-2020