Recalls / Class II
Class IID-1606-2020
Product
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.
- Affected lot / code info
- All lots with expiry between 10/2020-07/2023
Why it was recalled
CGMP Deviations: manufactured under the same conditions as those found to be subpotent.
Recalling firm
- Firm
- RLC Labs Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 1850 E Riverview Dr, N/A, Phoenix, Arizona 85034-6703
Distribution
- Quantity
- N/A
- Distribution pattern
- Nationwide in the United States
Timeline
- Recall initiated
- 2020-08-25
- FDA classified
- 2020-09-24
- Posted by FDA
- 2020-09-23
- Terminated
- 2023-11-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1606-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.