Drug product
WP Thyroid, Westhroid Pure, 2 Grain (130 mg) Thyroid USP packaged in a) 1,000 Tablets, NDC 64727-5950-2 ; b) 30 Tablets, NDC 64727-5950-4; c) 60 Tablets, NDC 64727-5950-5; d) 90 Tablets, NDC 64727-5950-6; e) 100 Tablets, NDC 64727-5950-1; Rx Only, Manufactured by: RLC Labs Phoenix, AZ 85034
D-1613-2020
Product summary
- Firm
- RLC Labs Inc.
- Event
- Event 86343
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1613-2020
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