Multi-event April 2023 FDA Recall Drug by Teva Pharmaceuticals Usa Inc

This Multi-event Class III drug recall was voluntarily initiated by Teva Pharmaceuticals Usa Inc on April 27, 2023 for the product Drug. The FDA reported the reason for recall as labeling. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0769-2023 TERMINATED D-0767-2023 TERMINATED D-0768-2023 TERMINATED D-0770-2023 TERMINATED D-0766-2023 TERMINATED

Recall Number: D-0769-2023

Reason for Recall
Labeling: Incorrect or Missing Package Insert
Initiated
04-27-2023
Reported
05-31-2023
Quantity
1908

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92133
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-29-2024
Product Description About Product Description
Full technical description of the product.
Fentanyl Buccal Tablets CII, 600mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-637-28

Batch or Lot Expiration Information

Lot# : 42617831, Exp 06/2023; 42619585, Exp 11/2023; 100029649, Exp 11/2024

Recall Number: D-0767-2023

Reason for Recall
Labeling: Incorrect or Missing Package Insert
Initiated
04-27-2023
Reported
05-31-2023
Quantity
397

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92133
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-29-2024
Product Description About Product Description
Full technical description of the product.
Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28

Batch or Lot Expiration Information

Lot# : 100020528, Exp 09/2024; 100026699, Exp 11/2024

Recall Number: D-0768-2023

Reason for Recall
Labeling: Incorrect or Missing Package Insert
Initiated
04-27-2023
Reported
05-31-2023
Quantity
1272

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92133
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-29-2024
Product Description About Product Description
Full technical description of the product.
Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28

Batch or Lot Expiration Information

Lot# : 100020351, Exp 11/2024; 100020522, Exp 09/2024; 100026700, Exp 11/2024

Recall Number: D-0770-2023

Reason for Recall
Labeling: Incorrect or Missing Package Insert
Initiated
04-27-2023
Reported
05-31-2023
Quantity
3032

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92133
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-29-2024
Product Description About Product Description
Full technical description of the product.
Fentanyl Buccal Tablets CII, 800mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-638-28

Batch or Lot Expiration Information

Lot# : 42617832, Exp 06/2023; 42619530, Exp 08/2023; 100020532, Exp 11/2024

Recall Number: D-0766-2023

Reason for Recall
Labeling: Incorrect or Missing Package Insert
Initiated
04-27-2023
Reported
05-31-2023
Quantity
438

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
92133
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Teva Pharmaceuticals USA Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-29-2024
Product Description About Product Description
Full technical description of the product.
Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28

Batch or Lot Expiration Information

Lot# 42617828, Exp 06/2023; 100020465, Exp 01/2024