Drug Enforcement D-0321-2024

Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.

Status

Ongoing

Classification

Class III

Report Date

February 21, 2024

Termination Date

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Product Information

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
Product quantity
12,916 cartons
Reason for recall
Discoloration: discolored tablets (shades of blue) mixed in with the white inert remainder tablets.
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
nationwide

Location & Firm

Recalling firm
Teva Pharmaceuticals USA, Inc
Address
400 Interpace Pkwy Bldg A, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0321-2024
Event ID
93867
Recall initiation date
January 25, 2024
Center classification date
February 12, 2024
Code info
Lot #: 100042978, Exp 7/31/2024
More code info
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