Recall Enforment Report D-1299-2020

Recall Details

Multi event Drug Recall Enforcement Report Class I voluntary initiated by Acella Pharmaceuticals, LLC, originally initiated on 05-22-2020 for the product 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. The product was recalled due to superpotent 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-1299-2020	05-22-2020	06-10-2020	Class I	29,304 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.	Superpotent Drug.	Terminated
D-1298-2020	05-22-2020	06-10-2020	Class I	112,140 bottles	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.	Superpotent Drug.	Terminated
D-1300-2020	05-22-2020	06-10-2020	Class I	49,128 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.	Superpotent Drug.	Terminated

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
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	85721 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1299-2020 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	Distributed Nationwide in the US and 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	Superpotent Drug. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	29,304 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	06-10-2020
Recall Initiation Date	05-22-2020 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	01-19-2022 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: M330J18-2A, M330J18-3 Exp. AUG-2020 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	85721 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1298-2020 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	Distributed Nationwide in the US and 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), 100-count bottles, Rx Only, Manufactured For: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-329-01.
Reason For Recall	Superpotent Drug. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	112,140 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	06-10-2020
Recall Initiation Date	05-22-2020 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	01-19-2022 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: M329H18-1, Exp. JUL-2020; M329J18-1, M329J18-2, M329J18-3 Exp. AUG-2020; M329M18-2 Exp. NOV-2020, M329A19-1 Exp. DEC-2020. 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
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	85721 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-1300-2020 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	Distributed Nationwide in the US and 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	Superpotent Drug. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	49,128 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	06-10-2020
Recall Initiation Date	05-22-2020 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Termination Date	01-19-2022 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: M331G18-1 Exp. JUN-2020, M331J18-1, M331J18-2, Exp. AUG-2020, M331M18-1, M331M18-2 Exp. NOV-2020 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.