Multi-event April 2021 FDA Recall Np Thyroid 15 by Acella Pharmaceuticals, Llc
This Multi-event Class I drug recall was voluntarily initiated by Acella Pharmaceuticals, Llc on April 29, 2021 for the product Np Thyroid 15. The FDA reported the reason for recall as subpotent drug. The product was distributed Nationwide and the recall is currently terminated.
Reported Recall Events
Recall Number: D-0396-2021
Subpotent Drug
04-29-2021
06-02-2021
a) 113,019 bottles; b) 44,900 bottles
Recall Profile & Regulatory Data
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Acella Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States including Puerto Rico
03-13-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
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
Recall Number: D-0397-2021
Subpotent Drug
04-29-2021
06-02-2021
154,726 bottles
Recall Profile & Regulatory Data
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Acella Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States including Puerto Rico
03-13-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of 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
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
Recall Number: D-0399-2021
Subpotent Drug
04-29-2021
06-02-2021
a) 69,289 bottles; b) 9,076 bottles
Recall Profile & Regulatory Data
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Acella Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States including Puerto Rico
03-13-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-0398-2021
Subpotent Drug
04-29-2021
06-02-2021
79,344 bottles
Recall Profile & Regulatory Data
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Acella Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States including Puerto Rico
03-13-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Recall Number: D-0395-2021
Subpotent Drug
04-29-2021
06-02-2021
a) 66,155 bottles; b) 26,212 bottles
Recall Profile & Regulatory Data
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Acella Pharmaceuticals, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Press Release
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States including Puerto Rico
03-13-2024
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
