Recall Enforment Report D-0259-2022

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Teligent Pharma, Inc., originally initiated on 10-19-2021 for the product Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 70512-025-05. The product was recalled due to defective container. The product was distributed nationwide and the recall is currently completed.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0259-2022	10-19-2021	12-01-2021	Class II	5400 units	Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 70512-025-05.	Defective Container	Completed
D-0258-2022	10-19-2021	12-01-2021	Class II	2664 bottles	Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05	Defective Container	Completed

Field Name	Field Value
Event ID	88884 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0259-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote 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 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	Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 70512-025-05.
Reason For Recall	Defective Container What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	5400 units 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	12-01-2021
Recall Initiation Date	10-19-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter 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	Teligent Pharma, Inc.
Code Info	Lot #: 15028, Exp 1/2023; 15379, Exp 3/2023. 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.
Status	Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.

Field Name	Field Value
Event ID	88884 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0258-2022 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote 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 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	Diclofenac Sodium Topical Solution USP, 1.5 w/w, 5 fl oz (150 mL) plastic bottles, Rx only, Teligent Pharma, Inc., Buena, New Jersey, 08310, NDC 52565-002-05
Reason For Recall	Defective Container What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	2664 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	12-01-2021
Recall Initiation Date	10-19-2021 What is the Recall Initiation Date? The date that the firm first began notifying the public or their consignees of the recall.
Initial Firm Notification	Letter 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	Teligent Pharma, Inc.
Code Info	Lot #: 15188, Exp 2/2023 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.
Status	Completed - A recall which has reached the point at which the firm has actually retrieved and impounded all outstanding product that could reasonably be expected to be recovered, or has completed all product corrections.