Recalls / Class I
Class ID-0036-2021
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 120, Thyroid Tablets, USP 2 grain (120 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-328-01
- 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
- Lot #: M328F19-3 Exp. 11/2020
Why it was recalled
Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
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
- 9816 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-09-17
- FDA classified
- 2020-10-19
- Posted by FDA
- 2020-10-28
- Terminated
- 2022-12-08
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0036-2021. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.