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.
Product description
NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01
Lot numbers, UPCs & expiration codes
Lot #: M327E19-1 Exp. 10/2020
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0035-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Sep 17, 2020
- FDA report date
- Oct 28, 2020
- Quantity
- 19,296 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Acella Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0035-2021, exactly as published.
Show all FDA fields
- City
- Alpharetta
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 86467
- Address
- 1880 Mcfarland Pkwy Ste 110-B
- Code information
- Lot #: M327E19-1 Exp. 10/2020
- Postal code
- 30005
- Report date
- Oct 28, 2020
- Product type
- Drugs
- Recall number
- D-0035-2021
- Classification
- Class I
- Recalling firm
- Acella Pharmaceuticals, LLC
- Product quantity
- 19,296 bottles
- Termination date
- Dec 8, 2022
- Reason for recall
- Subpotent Drug: FDA analysis found these products to be less than the labeled claim for the levothyroxine (T4) portion of the product.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NP Thyroid 15,Thyroid Tablets, USP 1/4 grain (15 mg) 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-327-01
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Sep 17, 2020
- Initial firm notification
- Press Release
- Center classification date
- Oct 19, 2020