Recall Enforment Report D-0396-2021

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Acella Pharmaceuticals, LLC, originally initiated on 04-29-2021 for the product 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 The product was recalled due to subpotent drug. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0396-2021	04-29-2021	06-02-2021	Class I	a) 113,019 bottles; b) 44,900 bottles	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	Subpotent Drug	Terminated
D-0397-2021	04-29-2021	06-02-2021	Class I	154,726 bottles	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	Subpotent Drug	Terminated
D-0395-2021	04-29-2021	06-02-2021	Class I	a) 66,155 bottles; b) 26,212 bottles	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	Subpotent Drug	Terminated
D-0399-2021	04-29-2021	06-02-2021	Class I	a) 69,289 bottles; b) 9,076 bottles	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	Subpotent Drug	Terminated
D-0398-2021	04-29-2021	06-02-2021	Class I	79,344 bottles	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	Subpotent Drug	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
42192-327	Np Thyroid 15	Levothyroxine, Liothyronine	Tablet	Oral	Acella Pharmaceuticals, Llc	Human Prescription Drug
42192-328	Np Thyroid 120	Levothyroxine, Liothyronine	Tablet	Oral	Acella Pharmaceuticals, Llc	Human Prescription Drug
42192-329	Np Thyroid 30	Levothyroxine, Liothyronine	Tablet	Oral	Acella Pharmaceuticals, Llc	Human Prescription Drug
42192-330	Np Thyroid 60	Levothyroxine, Liothyronine	Tablet	Oral	Acella Pharmaceuticals, Llc	Human Prescription Drug
42192-331	Np Thyroid 90	Levothyroxine, Liothyronine	Tablet	Oral	Acella Pharmaceuticals, Llc	Human Prescription Drug

Field Name	Field Value
Event ID	87843 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0396-2021 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States including Puerto Rico What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 113,019 bottles; b) 44,900 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	06-02-2021
Recall Initiation Date	04-29-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-13-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Acella Pharmaceuticals, LLC
Code Info	Lots: a) M329D20-1, M329D20-2, M329D20-3 Exp. 03/31/2022, ; b) M329D20-2 Exp. 03/31/2022 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	42192-329-01; 42192-329-07
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	87843 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0397-2021 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States including Puerto Rico What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	154,726 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	06-02-2021
Recall Initiation Date	04-29-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-13-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Acella Pharmaceuticals, LLC
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	42192-330-01
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	87843 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0395-2021 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States including Puerto Rico What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 66,155 bottles; b) 26,212 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	06-02-2021
Recall Initiation Date	04-29-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-13-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Acella Pharmaceuticals, LLC
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	42192-327-01; 42192-327-07
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	87843 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0399-2021 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States including Puerto Rico What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	a) 69,289 bottles; b) 9,076 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	06-02-2021
Recall Initiation Date	04-29-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-13-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Acella Pharmaceuticals, LLC
Code Info	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 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	42192-328-01; 42192-328-07
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.

Field Name	Field Value
Event ID	87843 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0398-2021 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. What is the Recall Classification? Numerical designation (I, II, or III) that is assigned by FDA to a particular product recall that indicates the relative degree of health hazard. For recalls pending classification, the entry will display as "Not Yet Classified".
Distribution Pattern	Nationwide within the United States including Puerto Rico What is the Distribution Pattern? General area of initial distribution such as states, countries, or territories. Note that subsequent distribution by the consignees to other parties may not be included.
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
Reason For Recall	Subpotent Drug What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	79,344 bottles Product Quantity The amount of product subject to recall.
Voluntary Mandated	Voluntary: Firm initiated Voluntary / Mandated Designates that a recall was initiated voluntarily by a firm on its own volition or after being requested to recall by FDA. “Mandatory” designates that a recall was initiated under a mandatory (statutory) recall authority, a court order, or FDA order.
Report Date	06-02-2021
Recall Initiation Date	04-29-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	03-13-2024 What is the Date Terminated? The date that FDA terminated the recall.
Initial Firm Notification	Press Release Initial Firm Notification of Consignee or Public The method(s) by which the firm initially notified the public or their consignees of a recall.
Product Type	Drugs
Recalling Firm	Acella Pharmaceuticals, LLC
Code Info	Lots: M331J19-10A, M331J19-11, M331J19-2A, M331J19-6A, Exp. 08/31/2021, M331K19-1, M331K19-2, M331K19-6, Exp. 09/30/2021 Code Information A list of all lot and/or serial numbers, product numbers, expiration dates, sell or use by dates, etc., which appear on the product or its labeling.
Recalled NDC Packages	42192-331-01
Status	Terminated - A recall where FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.