FDAFDA · Food and drugs·Recall number D-0439-2024
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
Published April 17, 2024 · Recall initiated: March 28, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- ISOTRETINOIN
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Distributor
- Nationwide in the USA
- Lot
- Lot #: 100044259, Exp 06/30/2025.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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