Recall Enforment Report D-0321-2024

Recall Details

Multi event Drug Recall Enforcement Report Class III voluntary initiated by Teva Pharmaceuticals USA, Inc, originally initiated on 01-25-2024 for the product Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67 The product was recalled due to discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.. The product was distributed nationwide and the recall is currently ongoing.

Recall Enforcement Reports

Recall Number	Recall Initiation Date	Report Date	Recall Classification	Quantity	Product Description	Recall Reason	Status
D-0321-2024	01-25-2024	02-21-2024	Class III	12,916 cartons	Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67	Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.	Ongoing
D-0322-2024	01-25-2024	02-21-2024	Class III	19,824 cartons	Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58	Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.	Ongoing

Recalled Products

NDC	Proprietary Name	Non-Proprietary Name	Dosage Form	Route Name	Company Name	Product Type
0555-9008	Nortrel 28 Day	Norethindrone And Ethinyl Estradiol	Kit		Teva Pharmaceuticals Usa, Inc.	Human Prescription Drug
0555-9009	Nortrel 21 Day	Norethindrone And Ethinyl Estradiol	Tablet	Oral	Teva Pharmaceuticals Usa, Inc.	Human Prescription Drug
0555-9010	Nortrel 28 Day	Norethindrone And Ethinyl Estradiol	Kit		Teva Pharmaceuticals Usa, Inc.	Human Prescription Drug
0555-9012	Nortrel 7/7/7 (28 Day Regimen)	Norethindrone And Ethinyl Estradiol	Kit		Teva Pharmaceuticals Usa, Inc.	Human Prescription Drug

Field Name	Field Value
Event ID	93867 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0321-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 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	Nortrel (norethindrone and ethinyl estradiol tablets USP) 0.5/35, packaged in cartons, each carton contains 3 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9008-67
Reason For Recall	Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	12,916 cartons 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	02-21-2024
Recall Initiation Date	01-25-2024 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	Teva Pharmaceuticals USA, Inc
Code Info	Lot #: 100042978, Exp 7/31/2024 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	0555-9009-80; 0555-9009-42; 0555-9010-79; 0555-9010-58; 0555-9008-79; 0555-9008-67
Status	Ongoing

Field Name	Field Value
Event ID	93867 What is the Event ID? A numerical designation assigned by FDA to a specific recall event (used for tracking purposes).
Recall Number	D-0322-2024 What is the Recall Number? An alphanumeric designation assigned by FDA to a specific, classified recalled product (used for tracking purposes).
Recall Classification	Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. 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 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	Nortrel 7/7/7 (norethindrone and ethinyl estradiol tablets USP- triphasic regimen), packaged in cartons, each carton contains 6 blister cards, each card contains 28 tablets, Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0555-9012-58
Reason For Recall	Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets. What is the Reason for Recall? Information describing how the product is defective.
Product Quantity	19,824 cartons 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	02-21-2024
Recall Initiation Date	01-25-2024 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	Teva Pharmaceuticals USA, Inc
Code Info	Lot #: 100040731, Exp 7/31/2024 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	0555-9012-79; 0555-9012-58
Status	Ongoing