FDA Recall D-1614-2020
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
WP Thyroid, Westhroid Pure, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 30-count bottles (NDC 64727-5550-4), b) 90-count bottles (NDC 64727-5550-6), c) 100-count bottles (NDC 64727-5550-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85024
Reason for recall
Subpotent Drug: FDA analysis found product to be subpotent
Recall record
- Recall number
D-1614-2020- 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