Class II
Ongoing
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
This recall is currently active, issued April 17, 2024. It was issued by Teva Pharmaceuticals Usa, Inc.
- Company
- Teva Pharmaceuticals Usa, Inc
- Recall Initiated
- March 28, 2024
- Posted
- April 17, 2024
- Recall Number
- D-0439-2024
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 5,304 3x10-cartons
- Firm Location
- Parsippany, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Superpotent Drug: The 3-month stability result for assay was found to be above specification limit
Distribution
Nationwide in the USA
Lot / Code Info
Lot #: 100044259, Exp 06/30/2025.
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