Recalls / Class I
Class ID-0395-2021
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
NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 42192-327-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
- Brand name
- Np Thyroid 15
- Generic name
- Levothyroxine, Liothyronine
- Active ingredients
- Levothyroxine, Liothyronine
- Route
- Oral
- NDCs
- 42192-327, 42192-329, 42192-330, 42192-331, 42192-328
- Affected lot / code info
- Lots: a) M327D20-1, M327D20-3 Exp. 03/31/2022, M327H19-3A Exp. 07/31/2021, M327L19-1 Exp. 04/30/2021; b) M327D20-1 Exp. 03/31/2022
Why it was recalled
Subpotent Drug
Recalling firm
- Firm
- Acella Pharmaceuticals, LLC
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1880 Mcfarland Pkwy Ste 110-B, N/A, Alpharetta, Georgia 30005
Distribution
- Quantity
- a) 66,155 bottles; b) 26,212 bottles
- Distribution pattern
- Nationwide within the United States including Puerto Rico
Timeline
- Recall initiated
- 2021-04-29
- FDA classified
- 2021-05-24
- Posted by FDA
- 2021-06-02
- Terminated
- 2024-03-13
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0395-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.