D-1606-2020 Class II Terminated
FDA drug recall D-1606-2020 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, Thyroid USP, [liothyronine (T3) 2.25 mcg and levothyroxine (T4) 9.5 mcg], 1/4 Grain (16.25 mg) Tablets, packaged in a) 30-count bottles, NDC 64727-5450-4; b) 60-count bottles, NDC 64727-5450-5; c) 90-count bottles, NDC 64727-5450-6; d) 100-count bottles, NDC 64727-5450-1; and e) 1,000-count bottles, NDC 64727-5450-2; 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