FDA Drug Recalls

Recalls / Class II

Class IID-1604-2020

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.

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
E-Mail
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-1604-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.

Class II recall: drug · FDA Drug Recalls