Recalls / Class I
Class ID-1615-2020
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences or death.
Product
Nature Throid, 1/2 Grain (32.5 mg) Thyroid USP [Liothyronine (T3) 4.5 mcg, Levothyroxine (T4) 19 mcg], packaged in a) 90-count bottles (NDC 64727-3299-6), b) 100-count bottles (NDC 64727-3299-1), Rx only, Manufactured by: RLC Labs Phoenix, AZ 85034
- Affected lot / code info
- Lot #: 099186, Exp. Date 11/2022
Why it was recalled
Subpotent Drug: FDA analysis found product 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-1615-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.