D-1608-2020 Class II Terminated
FDA drug recall D-1608-2020 was initiated by RLC Labs Inc. on August 25, 2020 and is designated Class II. Reason for recall: CGMP Deviations: manufactured under the same conditions as those found to be subpotent. The recall status is terminated (terminated November 8, 2023). Affected quantity: N/A.
Recall Details
- Product Type
- Drugs
- Report Date
- September 23, 2020
- Initiation Date
- August 25, 2020
- Termination Date
- November 8, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
WP Thyroid, Westhroid Pure, 3/4 Grain (48.75 mg) Thyroid USP, packaged in a) 1,000 Tablets, NDC 64727-5650-2 ; b) 30 Tablets, NDC 64727-5650-4; c) 60 Tablets, NDC 64727-5650-5; d) 90 Tablets, NDC 64727-5650-6; e) 100 Tablets, NDC 64727-5650-1; Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034
Reason for Recall
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Distribution Pattern
Nationwide in the United States
Code Information
All lots with expiry between 10/2020-07/2023