Np Thyroid 90 Tablet
FDA Recall NDC 42192-331

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 10 recorded enforcement report(s) associated with Np Thyroid 90 (NDC 42192-331). A significant event, classified as Class I, was initiated on Apr 29, 2021 by Acella Pharmaceuticals, Llc. The reported reason for this action was: "Subpotent Drug"

This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.

Reported Recall Events

D-0396-2021TERMINATEDD-0397-2021TERMINATEDD-0399-2021TERMINATEDD-0398-2021TERMINATEDD-0395-2021TERMINATEDD-0036-2021TERMINATEDD-0035-2021TERMINATEDD-1300-2020TERMINATEDD-1299-2020TERMINATEDD-1298-2020TERMINATED

April 2021 Class I Recall: Subpotent Drug

Recall Number
D-0396-2021
Class I Terminated
Reason for Recall
Subpotent Drug
Initiated
Apr 29, 2021
Reported
Jun 02, 2021
Quantity
a) 113,019 bottles; b) 44,900 bottles

Recall Profile & Regulatory Data

Event ID
87843
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Acella Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States including Puerto Rico
Termination Date
Mar 13, 2024
Product Description
NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-count bottles (NDC 42192-329-01) and b) 7-count bottles (NDC 42192-329-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Batch or Lot Expiration Information
Lot# Lots: a) M329D20-1, M329D20-2, M329D20-3 Exp. 03/31/2022, ; b) M329D20-2 Exp. 03/31/2022
Affected Packages Involved in this Recall
42192-327-01Product
42192-327-30Product
42192-327-90Product
42192-329-01Product
42192-329-30Product
42192-329-10Product
42192-329-90Product
42192-330-01Product
42192-330-30Product
42192-330-10Product
42192-330-90Product
42192-331-01Product
42192-331-30Product
42192-331-10Product
42192-331-90Product
42192-328-01Product
42192-328-30Product
42192-328-90Product
42192-329-07Product

April 2021 Class I Recall: Subpotent Drug

Recall Number
D-0397-2021
Class I Terminated
Reason for Recall
Subpotent Drug
Initiated
Apr 29, 2021
Reported
Jun 02, 2021
Quantity
154,726 bottles

Recall Profile & Regulatory Data

Event ID
87843
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Acella Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States including Puerto Rico
Termination Date
Mar 13, 2024
Product Description
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
Batch or Lot Expiration Information
Lot# 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
Affected Packages Involved in this Recall
42192-327-01Product
42192-327-30Product
42192-327-90Product
42192-329-01Product
42192-329-30Product
42192-329-10Product
42192-329-90Product
42192-330-01Product
42192-330-30Product
42192-330-10Product
42192-330-90Product
42192-331-01Product
42192-331-30Product
42192-331-10Product
42192-331-90Product
42192-328-01Product
42192-328-30Product
42192-328-90Product

April 2021 Class I Recall: Subpotent Drug

Recall Number
D-0399-2021
Class I Terminated
Reason for Recall
Subpotent Drug
Initiated
Apr 29, 2021
Reported
Jun 02, 2021
Quantity
a) 69,289 bottles; b) 9,076 bottles

Recall Profile & Regulatory Data

Event ID
87843
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Acella Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States including Puerto Rico
Termination Date
Mar 13, 2024
Product Description
NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-count bottles (NDC 42192-328-01) and b) 7-count bottles (NDC 42192-328-07) Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Batch or Lot Expiration Information
Lot# : a) M328H19-2B, M328J19-11, M328J19-2A, M328J19-3A, M328J19-4A M328J19-5A, M328J19-6A, M328J19-7A, Exp. 08/31/2021, M328K19-2, M328K19-4A, Exp. 09/30/2021; b) M328J19-9B Exp. 08/31/2021
Affected Packages Involved in this Recall
42192-327-01Product
42192-327-30Product
42192-327-90Product
42192-329-01Product
42192-329-30Product
42192-329-10Product
42192-329-90Product
42192-330-01Product
42192-330-30Product
42192-330-10Product
42192-330-90Product
42192-331-01Product
42192-331-30Product
42192-331-10Product
42192-331-90Product
42192-328-01Product
42192-328-30Product
42192-328-90Product
42192-328-07Product

April 2021 Class I Recall: Subpotent Drug

Recall Number
D-0398-2021
Class I Terminated
Reason for Recall
Subpotent Drug
Initiated
Apr 29, 2021
Reported
Jun 02, 2021
Quantity
79,344 bottles

Recall Profile & Regulatory Data

Event ID
87843
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Acella Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States including Puerto Rico
Termination Date
Mar 13, 2024
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
Batch or Lot Expiration Information
Lot# Lots: M331J19-10A, M331J19-11, M331J19-2A, M331J19-6A, Exp. 08/31/2021, M331K19-1, M331K19-2, M331K19-6, Exp. 09/30/2021
Affected Packages Involved in this Recall
42192-327-01Product
42192-327-30Product
42192-327-90Product
42192-329-01Product
42192-329-30Product
42192-329-10Product
42192-329-90Product
42192-330-01Product
42192-330-30Product
42192-330-10Product
42192-330-90Product
42192-331-01Product
42192-331-30Product
42192-331-10Product
42192-331-90Product
42192-328-01Product
42192-328-30Product
42192-328-90Product

April 2021 Class I Recall: Subpotent Drug

Recall Number
D-0395-2021
Class I Terminated
Reason for Recall
Subpotent Drug
Initiated
Apr 29, 2021
Reported
Jun 02, 2021
Quantity
a) 66,155 bottles; b) 26,212 bottles

Recall Profile & Regulatory Data

Event ID
87843
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Acella Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States including Puerto Rico
Termination Date
Mar 13, 2024
Product Description
NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-count bottles (NDC 42192-327-01) and b) 7-count bottles (NDC 42192-327-07), Rx Only, Manufactured For: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Batch or Lot Expiration Information
Lot# Lots: a) M327D20-1, M327D20-3 Exp. 03/31/2022, M327H19-3A Exp. 07/31/2021, M327L19-1 Exp. 04/30/2021; b) M327D20-1 Exp. 03/31/2022
Affected Packages Involved in this Recall
42192-327-01Product
42192-327-30Product
42192-327-90Product
42192-329-01Product
42192-329-30Product
42192-329-10Product
42192-329-90Product
42192-330-01Product
42192-330-30Product
42192-330-10Product
42192-330-90Product
42192-331-01Product
42192-331-30Product
42192-331-10Product
42192-331-90Product
42192-328-01Product
42192-328-30Product
42192-328-90Product
42192-327-07Product

September 2020 Class I Recall: Subpotent Drug

Recall Number
D-0036-2021
Class I Terminated
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.
Initiated
Sep 17, 2020
Reported
Oct 28, 2020
Quantity
9816 bottles

Recall Profile & Regulatory Data

Event ID
86467
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Acella Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Dec 08, 2022
Product Description
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
Batch or Lot Expiration Information
Lot# : M328F19-3 Exp. 11/2020
Affected Packages Involved in this Recall
42192-327-01Product
42192-327-30Product
42192-327-90Product
42192-329-01Product
42192-329-30Product
42192-329-10Product
42192-329-90Product
42192-330-01Product
42192-330-30Product
42192-330-10Product
42192-330-90Product
42192-331-01Product
42192-331-30Product
42192-331-10Product
42192-331-90Product
42192-328-01Product
42192-328-30Product
42192-328-90Product

September 2020 Class I Recall: Subpotent Drug

Recall Number
D-0035-2021
Class I Terminated
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.
Initiated
Sep 17, 2020
Reported
Oct 28, 2020
Quantity
19,296 bottles

Recall Profile & Regulatory Data

Event ID
86467
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Acella Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Dec 08, 2022
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
Batch or Lot Expiration Information
Lot# : M327E19-1 Exp. 10/2020
Affected Packages Involved in this Recall
42192-327-01Product
42192-327-30Product
42192-327-90Product
42192-329-01Product
42192-329-30Product
42192-329-10Product
42192-329-90Product
42192-330-01Product
42192-330-30Product
42192-330-10Product
42192-330-90Product
42192-331-01Product
42192-331-30Product
42192-331-10Product
42192-331-90Product
42192-328-01Product
42192-328-30Product
42192-328-90Product

May 2020 Class I Recall: Superpotent Drug.

Recall Number
D-1300-2020
Class I Terminated
Reason for Recall
Superpotent Drug.
Initiated
May 22, 2020
Reported
Jun 10, 2020
Quantity
49,128 bottles

Recall Profile & Regulatory Data

Event ID
85721
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Acella Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US and Puerto Rico
Termination Date
Jan 19, 2022
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.
Batch or Lot Expiration Information
Lot# Lots: M331G18-1 Exp. JUN-2020, M331J18-1, M331J18-2, Exp. AUG-2020, M331M18-1, M331M18-2 Exp. NOV-2020
Affected Packages Involved in this Recall
42192-327-01Product
42192-327-30Product
42192-327-90Product
42192-329-01Product
42192-329-30Product
42192-329-10Product
42192-329-90Product
42192-330-01Product
42192-330-30Product
42192-330-10Product
42192-330-90Product
42192-331-01Product
42192-331-30Product
42192-331-10Product
42192-331-90Product
42192-328-01Product
42192-328-30Product
42192-328-90Product

May 2020 Class I Recall: Superpotent Drug.

Recall Number
D-1299-2020
Class I Terminated
Reason for Recall
Superpotent Drug.
Initiated
May 22, 2020
Reported
Jun 10, 2020
Quantity
29,304 bottles

Recall Profile & Regulatory Data

Event ID
85721
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Acella Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US and Puerto Rico
Termination Date
Jan 19, 2022
Product Description
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.
Batch or Lot Expiration Information
Lot# Lots: M330J18-2A, M330J18-3 Exp. AUG-2020
Affected Packages Involved in this Recall
42192-327-01Product
42192-327-30Product
42192-327-90Product
42192-329-01Product
42192-329-30Product
42192-329-10Product
42192-329-90Product
42192-330-01Product
42192-330-30Product
42192-330-10Product
42192-330-90Product
42192-331-01Product
42192-331-30Product
42192-331-10Product
42192-331-90Product
42192-328-01Product
42192-328-30Product
42192-328-90Product

May 2020 Class I Recall: Superpotent Drug.

Recall Number
D-1298-2020
Class I Terminated
Reason for Recall
Superpotent Drug.
Initiated
May 22, 2020
Reported
Jun 10, 2020
Quantity
112,140 bottles

Recall Profile & Regulatory Data

Event ID
85721
Classification
Class I
Enforcement Status
Terminated
Recalling Firm
Acella Pharmaceuticals, LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the US and Puerto Rico
Termination Date
Jan 19, 2022
Product Description
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.
Batch or Lot Expiration Information
Lot# 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.
Affected Packages Involved in this Recall
42192-327-01Product
42192-327-30Product
42192-327-90Product
42192-329-01Product
42192-329-30Product
42192-329-10Product
42192-329-90Product
42192-330-01Product
42192-330-30Product
42192-330-10Product
42192-330-90Product
42192-331-01Product
42192-331-30Product
42192-331-10Product
42192-331-90Product
42192-328-01Product
42192-328-30Product
42192-328-90Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.