Drug product
Nature-Throid, Thyroid USP [liothyronine (T3) 20.25 mcg and levothyroxine (T4) 85.5 mcg], 2.25 Grain (146.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3309-4; b) 60-count bottles, NDC 64727-3309-5; c) 90-count bottles, NDC 64727-3309-6; d) 100-count bottles, NDC 64727-3309-1; and e) 1,000-count bottles, NDC 64727-3309-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.
D-1603-2020
Product summary
- Firm
- RLC Labs Inc.
- Event
- Event 86343
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1603-2020
Official wording
Reason: CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Code information: All lots with expiry between 10/2020-07/2023
Distribution pattern: Nationwide in the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations
-
Potency or specification failure
subpotent