FDA Recall D-1617-2020
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, 1.25 Grain (81.25 mg) Thyroid USP [Liothyronine (T3) 11.25 mcg, Levothyroxine (T4) 47.5 mcg], 100-count bottles, Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024, NDC 64727-3303-1
Reason for recall
Subpotent Drug: FDA analysis found product to be subpotent
Recall record
- Recall number
D-1617-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- 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