Drug product
Nature-Throid, Thyroid USP [liothyronine (T3) 22.5 mcg and levothyroxine (T4) 95 mcg], 2.5 Grain (162.5 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-3310-4; b) 60-count bottles, NDC 64727-3310-5; c) 90-count bottles, NDC 64727-3310-6; d) 100-count bottles, NDC 64727-3310-1; and e) 1,000-count bottles, NDC 64727-3310-2; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034.
D-1604-2020
Product summary
- Firm
- RLC Labs Inc.
- Event
- Event 86343
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1604-2020
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