Recalls / Class I
Class ID-0397-2021
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 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-330-01
- 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: M330D20-1, M330D20-2 Exp. 03/31/2022; M330J19-2A, M330J19-4A , M330J19-5A, M330J19-6A, M330J19-7A, M330J19-9A Exp. 08/31/2021; M330K19-10, M330K19-1A, M330K19-9 Exp. 09/30/2021
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
- 154,726 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-0397-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.