Multi-event February 2021 FDA Recall Drug by Teligent Pharma, Inc.

This Multi-event Class III drug recall was voluntarily initiated by Teligent Pharma, Inc. on February 2, 2021 for the product Drug. The FDA reported the reason for recall as failed impurities/ degradation specifications - oos for know impurity betamethasone 17- propionate.. The product was distributed Nationwide and the recall is currently terminated.

Reported Recall Events

D-0338-2021 TERMINATED D-0340-2021 TERMINATED D-0339-2021 TERMINATED

Recall Number: D-0338-2021

Reason for Recall
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Initiated
02-02-2021
Reported
05-05-2021
Quantity
104,784 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87266
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.
Teligent Pharma, 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.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2024
Product Description About Product Description
Full technical description of the product.
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-15

Batch or Lot Expiration Information

Lot# : 14297, Exp 9/2021; 15372, Exp 3/2022; 15841, Exp 8/2022

Recall Number: D-0340-2021

Reason for Recall
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Initiated
02-02-2021
Reported
05-05-2021
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87266
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.
Teligent Pharma, 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.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2024
Product Description About Product Description
Full technical description of the product.
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 15 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, Distributed by: McKesson Corporation dba Sky Packaging 4971 Southbridge Blvd., Suite 101 Memphis, TN 38141, NDC 63739-996-15

Batch or Lot Expiration Information

Lot# : 15644, Exp 5/2022

Recall Number: D-0339-2021

Reason for Recall
Failed Impurities/ Degradation Specifications - OOS for know impurity Betamethasone 17- propionate.
Initiated
02-02-2021
Reported
05-05-2021
Quantity
79,416 tubes

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
87266
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.
Teligent Pharma, 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.
USA Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-15-2024
Product Description About Product Description
Full technical description of the product.
Betamethasone Dipropionate Ointment USP, 0.05% (Augmented), packaged in 50 grams tubes, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 08310, NDC 52565-019-51

Batch or Lot Expiration Information

Lot# : 14297, Exp 9/2021; 15757, Exp 6/2022; 15840, Exp 7/2022; 15970, Exp 9/2022; 15993, Exp 9/2022