← FDA ENFORCEMENT
D-0439-2024Class II

Teva Pharmaceuticals USA, Inc

Recalling firm
Teva Pharmaceuticals USA, Inc
Product type
Drug
Status
Ongoing
Report date
2024-04-17
Distribution
Nationwide in the USA
Firm state
NJ
Product quantity
5,304 3x10-cartons
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

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

Code / lot info

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

Other recalls SPEQ maps to Validation & Qualification
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See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.