FDA Recall D-1619-2020

RLC Labs Inc. · Phoenix, AZ

Class I — life-threatening Terminated 1170 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

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

Lot / code: Lot #: 109286, Exp. Date 10/2022

Quantity: N/A

Reason for recall

Subpotent Drug: FDA analysis found product to be subpotent

Recall record

Recall number: D-1619-2020
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: Nationwide in the United States
Recall initiated: 2020-08-25
Classified by FDA Center: 2020-09-24
FDA published: 2020-09-23
Terminated: 2023-11-08
Recalling firm: RLC Labs Inc.
Firm location: Phoenix, AZ

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