FDA Recall D-0321-2024

Teva Pharmaceuticals USA, Inc · Parsippany, NJ

Class III Ongoing 840 days on record

Lower impact — Class III recall — product violates FDA labeling or manufacturing standards but is unlikely to cause adverse health consequences.

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

Lot / code: Lot #: 100042978, Exp 7/31/2024

Quantity: 12,916 cartons

Reason for recall

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

Recall record

Recall number: D-0321-2024
Classification: Class III
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: nationwide
Recall initiated: 2024-01-25
Classified by FDA Center: 2024-02-12
FDA published: 2024-02-21
Recalling firm: Teva Pharmaceuticals USA, Inc
Firm location: Parsippany, NJ

Drug identification

Brand name(s): NORTREL
Generic name(s): NORETHINDRONE AND ETHINYL ESTRADIOL
Manufacturer(s): Teva Pharmaceuticals USA, Inc.
NDC(s): 0555-9008, 0555-9009, 0555-9010

Operational response

Class III recalls are unlikely to cause adverse health consequences but indicate a violation of FDA labeling or manufacturing standards. Pull from active dispensing per your operational policy.

For the official FDA enforcement record, see FDA's Recall Search.

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