FDA Recall D-0439-2024

Teva Pharmaceuticals USA, Inc · Parsippany, NJ

Class II Ongoing 777 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Isotretinoin Capsules, USP 40mg, 30-count 3x10 blister packs per carton, Rx Only, Manufactured For: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054. Blister Pack NDC 0591-2436-45, Carton NDC 0591-2436-15

Lot / code: Lot #: 100044259, Exp 06/30/2025.

Quantity: 5,304 3x10-cartons

Reason for recall

Superpotent Drug: The 3-month stability result for assay was found to be above specification limit

Recall record

Recall number: D-0439-2024
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2024-03-28
Classified by FDA Center: 2024-04-08
FDA published: 2024-04-17
Recalling firm: Teva Pharmaceuticals USA, Inc
Firm location: Parsippany, NJ

Drug identification

Brand name(s): ISOTRETINOIN
Generic name(s): ISOTRETINOIN
Manufacturer(s): Actavis Pharma, Inc.
NDC(s): 0591-2433, 0591-2434, 0591-2451, 0591-2435, 0591-2501, 0591-2436
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

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

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