Why it was recalled
Subpotent Drug
Product description
NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-331-01
Lot numbers, UPCs & expiration codes
Lots: M331J19-10A, M331J19-11, M331J19-2A, M331J19-6A, Exp. 08/31/2021, M331K19-1, M331K19-2, M331K19-6, Exp. 09/30/2021
Where it was sold
Nationwide within the United States including Puerto Rico
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-0398-2021
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Apr 29, 2021
- FDA report date
- Jun 2, 2021
- Quantity
- 79,344 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Acella Pharmaceuticals, LLC
Original FDA data
Every field from FDA enforcement report D-0398-2021, exactly as published.
Show all FDA fields
- City
- Alpharetta
- State
- GA
- Status
- Terminated
- Country
- United States
- Event ID
- 87843
- Address
- 1880 Mcfarland Pkwy Ste 110-B
- Code information
- Lots: M331J19-10A, M331J19-11, M331J19-2A, M331J19-6A, Exp. 08/31/2021, M331K19-1, M331K19-2, M331K19-6, Exp. 09/30/2021
- Postal code
- 30005
- Report date
- Jun 2, 2021
- Product type
- Drugs
- Recall number
- D-0398-2021
- Classification
- Class I
- Recalling firm
- Acella Pharmaceuticals, LLC
- Product quantity
- 79,344 bottles
- Termination date
- Mar 13, 2024
- Reason for recall
- Subpotent Drug
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005, NDC 42192-331-01
- Distribution pattern
- Nationwide within the United States including Puerto Rico
- Recall initiation date
- Apr 29, 2021
- Initial firm notification
- Press Release
- Center classification date
- May 24, 2021