Recalls / Class I
Class ID-1298-2020
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
NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-329-01.
- 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: M329H18-1, Exp. JUL-2020; M329J18-1, M329J18-2, M329J18-3 Exp. AUG-2020; M329M18-2 Exp. NOV-2020, M329A19-1 Exp. DEC-2020.
Why it was recalled
Superpotent 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
- 112,140 bottles
- Distribution pattern
- Distributed Nationwide in the US and Puerto Rico
Timeline
- Recall initiated
- 2020-05-22
- FDA classified
- 2020-06-08
- Posted by FDA
- 2020-06-10
- Terminated
- 2022-01-19
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1298-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.